JP5274071B2 - Fibromyalgia treatment - Google Patents

Description

  The present invention relates to a novel medicament for the treatment of fibromyalgia.

Fibromyalgia is also called fibromyalgia asyndrome (hereinafter abbreviated as FMS), and it causes pain that persists over a wide range of the body for a long time, and the sensory effect on stimulation is systemic. It is characterized by being strengthened. There are currently no fixed opinions such as viral infection theory, cytokine imbalance theory, chemical substance poisoning theory, and endocrine abnormality theory. According to the diagnostic criteria of the American College of Rheumatology (1990), fibromyalgia is diagnosed when there is general pain that lasts for 3 months or more and tenderness is detected in 11 or more of the 18 tender points by finger palpation. I can do it. Symptoms range from those complaining of mild pain to those in which daily life is harmed by severe pain over a long period of time, and there are many cases where treatment is difficult.
In general, the chief complaint of FMS patients is pain, which has been treated with drug therapy. Some standard drug therapies used in the treatment of FMS include analgesics, hypnotic sedatives, prescription drugs such as immunosuppressants, and psychotherapy, all of which are used alone or It is difficult to say that any combination of drugs is effective for the treatment of FMS, and it can be said that there has not been established as a sputum therapy for FMS at present.
Elcatonin, on the other hand, is a compound obtained by chemically modifying the disulfide bond at positions 1 and 7 of natural eel calcitonin. 1-Butylic acid-7- (L-2-aminobutyric acid) -26-L-aspartic acid It is known as -27-L-valine-29-L-alanine calcitonin. Here, although elcatonin is known to have an indication for osteoporosis pain, salmon calcitonin, which is a kind of calcitonin, is clearly ineffective for the treatment of FMS (non-patented) Reference 1) and elcatonin were considered not to be expected to have a therapeutic effect on FMS in the same manner as salmon calcitonin.
Bessette L. et.al.Scand J Rheumatol. 1998; 27 (2): 112-6

  An object of the present invention is to provide a therapeutic agent superior to a conventionally known FMS therapeutic agent. Furthermore, it aims at providing the therapeutic agent of the disease relevant to the symptom accompanying FMS, especially the pain accompanying FMS.

Examples of natural calcitonin include chicken calcitonin, eel calcitonin, human calcitonin, salmon calcitonin, or porcine calcitonin. Here, as described above, salmon calcitonin is known to have no effect on the treatment of FMS (Bessette L. et.al. Scand J Rheumatol. 1998; 27 (2): 112-6). Therefore, it is considered that other natural calcitonin was predicted to have no therapeutic effect in FMS. However, contrary to the above prediction, the present inventor has conducted intensive studies on the therapeutic effect of elcatonin on FMS, and as a result, surprisingly found that the elcatonin has an effect on the therapeutic effect of FMS, particularly on the improvement of pain. It came to complete. That is, the present invention includes the following.
[1] A therapeutic agent for fibromyalgia containing elcatonin.
[1-2] The therapeutic agent for fibromyalgia according to claim 1, which is a therapeutic agent for pain associated with fibromyalgia.
[2] The therapeutic agent for fibromyalgia according to the above [1] or [1-2] for a patient with osteoporosis.
[3] The therapeutic agent for fibromyalgia according to the above [1] to [2] for a patient whose effect was not obtained by administration of an analgesic adjuvant.
In addition, when the item number to be quoted is indicated by a range as in [1] to [2] above, and a term having a branch number such as [1-2] is arranged in the range, [1] -2] means that a term having a branch number such as is also cited. The same applies to the following.
[3-2] The therapeutic agent for fibromyalgia according to any one of the above [1] to [3] for a patient whose effect was not obtained by milnacipran or a salt thereof.
[4] The therapeutic agent for fibromyalgia according to any one of the above [1] to [3-2] for improving low back pain.
[4-2] The therapeutic agent for fibromyalgia according to any one of [1] to [3-2] above for improving low back pain.
[5] The treatment for fibromyalgia according to any one of [1] to [4-2] above, wherein 5 to 80 units of elcatonin is administered three or more times a week 1 to 7 times Agent.
[5-2] The above [1] to [4-2] for reducing VAS to 50 mm or less by administering 5 to 80 units of elcatonin three or more times a week 1 to 7 times a week ] The therapeutic agent for fibromyalgia according to any one of the above.
[5-3] The treatment for fibromyalgia according to any one of [1] to [4-2] above, wherein 5 to 80 units of elcatonin is administered three times or more once a week. Agent.
[5-4] The above [1] to [4-2] for reducing VAS to 50 mm or less by administering 5 to 80 units of elcatonin three times or more once a week. The therapeutic agent for fibromyalgia according to any one of the above.
[6] The therapeutic agent for fibromyalgia according to any one of the above [1] to [5-2], which is administered in combination with a selective serotonin / noradrenaline reuptake inhibitor.
[7] Any of the above [1] to [5-2] for administration after the selective serotonin / noradrenaline reuptake inhibitor is administered, in combination with the selective serotonin / noradrenaline reuptake inhibitor or alone The therapeutic agent for fibromyalgia according to any one of the above.
[8] The therapeutic agent for fibromyalgia according to any one of [1] to [5-2], wherein a selective serotonin / noradrenaline reuptake inhibitor is blended.
[9] The therapeutic agent for fibromyalgia according to any one of the above [6] to [8], wherein the selective serotonin / noradrenaline reuptake inhibitor is milnacipran or a salt thereof.
[10] The therapeutic agent for fibromyalgia according to [9] above, wherein milnacipran or a salt thereof is administered at 30 mg or more per day.
[11] Use of elcatonin for the production of the therapeutic agent for fibromyalgia according to any one of [1] to [10].

  The therapeutic agent of the present invention provides a therapeutic agent for FMS that has substantially no side effects, that is, extremely few or no side effects, a therapeutic agent for symptoms associated with FMS, particularly a therapeutic agent for pain associated with FMS. Has the effect of enabling

The present invention will be specifically described below.
FMS is called fibromyalgia syndrome or fibromyalgia and is the disease that causes pain that is widespread and lasts for a long time. FMS is characterized by a systemic enhancement of sensory perception related to stimuli. FMS patients exhibit abnormal analgesia through both allodynia (pain from innocuous stimuli) and hyperalgesia (increased sensitivity to painful stimuli). Syndromes classified according to the American College of Rheumatology criteria include pain in the quadrant of the body as well as more than 3 months along the spinal cord. Furthermore, pain occurs in 11 or more of 18 “tenderness points” when pressed with a force of 4 kg or less during palpation (Frederick Wolfe et. Al., Arthritis and Reumatism, vol.33, No.2, p160- , 1990). Other symptoms associated with FMS include fatigue, sleep, or memory impairment. That is, specific examples of symptoms associated with FMS include pain, fatigue, sleep disorders, and memory disorders.

Pain associated with FMS is associated with various underlying diseases or disorders and can be either acute or chronic. Chronic or stubborn pain often lasts for years or decades. The therapeutic agent for FMS of the present invention is exemplified as a medicament for alleviating the symptoms of FMS, particularly reducing or relieving pain pain and reducing the number of tender points. More preferably, the FMS therapeutic agent of the present invention is exemplified as a medicament for treating FMS symptoms. As an embodiment for treating the symptoms of FMS, an embodiment in which the number of tender points is 10 or less is exemplified, preferably 9 or less, more preferably 8 or less, and even more preferably 7 or less.
The body part that relieves pain of the FMS therapeutic agent of the present invention particularly includes the lower back and the lower back. That is, the therapeutic agent for FMS of the present invention aims to improve low back pain and aims to improve low back pain.

The degree of pain associated with FMS can be expressed by, for example, measuring by a measurement method using a score called VAS (Visual Analogue Scale). The VAS is a 10 cm long horizontal or vertical line as shown in FIG. 1, and is described as “no pain” at the left end (or lower part) and “unbearable pain” at the right end (or head). The patient puts the intensity of pain when necessary on this line with a cross in his / her corresponding part. This distance is measured in units of millimeters from the left end (or lower part), and this is used as a pain score.
The degree of the FMS therapeutic agent of the present invention is not limited as long as pain can be reduced. However, when the VAS is used as an index, for example, the FMS therapeutic agent can be reduced to 50 mm or less.

Elcatonin contained in the FMS therapeutic agent of the present invention is a compound obtained by chemically modifying the 1,7-position disulfide bond of natural eel calcitonin, which is 1-butyric acid-7- (L-2-aminobutyric acid). ) -26-L-aspartic acid-27-L-valine-29-L-alanine calcitonin. Elcatonin can be obtained by a known method.
The dose of elcatonin may be appropriately determined in consideration of the subject to be treated, the severity of pain, the method of administration, and the judgment of the prescribing doctor. For example, the dose of elcatonin is 5 to 7 times per week. Examples include the case where 80 units of elcatonin is administered three times or more, and the case where 5 to 80 units of elcatonin is administered three times or more once a week. The upper limit of the dose of elcatonin per unit is exemplified by 80 units or less, preferably 70 units or less, more preferably 60 units or less, further preferably 50 units or less, particularly preferably 40 units or less, Most preferred is 30 units or less, and the lower limit is 1 unit or more, preferably 3 units or more, more preferably 5 units or more, still more preferably 10 units or more, and particularly preferably 15 units or more. The VAS, which is the above-mentioned pain index, can be reduced by such dosage and administration frequency. As a result of lowering VAS, the value of VAS is preferably 90 mm or less, more preferably 80 mm or less, further preferably 70 mm or less, particularly preferably 60 mm or less, and 50 mm or less. Most preferably. For example, as the FMS therapeutic agent of the present invention, an FMS therapeutic agent for reducing VAS to 50 mm or less by administering 5 to 80 units of elcatonin three times or more once a week. Alternatively, an FMS therapeutic agent for reducing VAS to 50 mm or less by administering 5 to 80 units of elcatonin three times or more once a week. Further, the administration period of elcatonin is exemplified by a minimum of 1 day from the start of administration of elcatonin, preferably 1 week or more, more preferably 2 weeks or more, further preferably 3 weeks or more, particularly preferably 4 weeks or more. 6 weeks or more is most preferable, and the upper limit is not particularly limited as long as it is an administration period in which VAS is 50 mm or less or an administration period in which the number of tender points is 10 or less, but for example, 6 months or less is exemplified. Months or less is preferable, 4 months or less is more preferable, 3 months or less is further preferable, and 2 months or less is particularly preferable.

The FMS therapeutic agent of the present invention can be used in combination with other drugs as long as it does not inhibit the therapeutic effect. For example, it can be administered in combination with a selective serotonin / noradrenaline reuptake inhibitor. The selective serotonin / noradrenaline reuptake inhibitor is sometimes referred to as SNRI, and common SNRI compounds include venlafaxine, duloxetine, milnacipran, and the like. Milnacipran is an antidepressant already on the market and is known as F2207, TN-912, dulcipran, midicipran, midariplan, and its chemical name is cis- (±) -2- (aminomethyl) -N, N-diethyl-1-phenyl-cyclopropanecarboxamide.
The FMS therapeutic agent of the present invention can be administered in combination with a selective serotonin / noradrenaline reuptake inhibitor after the selective serotonin / noradrenaline reuptake inhibitor has been administered, or can be administered alone.
Thus, the FMS therapeutic agent of the present invention is a composition containing elcatonin, and a selective serotonin / noradrenaline reuptake inhibitor may be incorporated.

  Milnacipran, which is used as a selective serotonin / noradrenaline reuptake inhibitor, can be used in the same manner, and pharmaceutically acceptable salts include salts formed with pharmaceutically acceptable acidic substances. Without limitation, for example, hydrochloride, hydrobromide, nitrate, sulfate, hydrogen sulfate, phosphate, acetate, lactate, succinate, citrate, maleate, tartrate , Fumarate, methanesulfonate, p-toluenesulfonate, camphorsulfonate, mandelate and the like.

  The daily dosage of milnacipran when used in combination with the therapeutic agent of the present invention is FMS and / or a dosage of milnacipran as an active ingredient, which is not less than a dose at which a therapeutic effect on symptoms associated with FMS appears. The amount of milnacipran administered to carry out the present invention in terms of the above should be appropriately determined within the above range in consideration of the subject to be treated, the severity of the pain, the administration method and the judgment of the prescribing physician. That's fine. The daily dose of milnacipran or a salt thereof is exemplified by 15 mg or more, preferably 25 mg or more, more preferably 30 mg or more, further preferably 35 mg or more, particularly preferably 40 mg or more, and most preferably 50 mg or more. As for the number of administrations, the dose can be administered once a day or divided into a plurality of times.

The target patient of the FMS therapeutic agent containing the elcatonin of the present invention as an active ingredient is not particularly limited as long as it is an FMS patient, but among them, it is particularly effective for FMS patients with osteoporosis, and by administering an analgesic. It is effectively used for patients who have not been able to obtain an effect, in particular, FMS patients who have not been able to obtain an effect even if milnacipran or a salt thereof is administered.
Examples of FMS patients who were unable to obtain an effect include patients who were unable to reduce VAS even when the drug was administered, or patients who were unable to treat FMS symptoms even when the drug was administered, and the drug was administered. Even so, patients who have not been able to reduce VAS are preferred. There is also another embodiment in which a patient who has not been able to treat FMS symptoms even after administration of a drug is preferred. Examples of patients whose VAS could not be reduced even after administration of a drug include patients whose VAS could not be lowered to 90 mm or less even after administration of a drug, preferably patients who could not lower it to 80 mm or less, Patients who have not been lowered to 70 mm or less are more preferred, patients who have not been lowered to 60 mm or less are more preferred, patients who have not been lowered to 60 mm or less are particularly preferred, and patients who have not been lowered to 50 mm or less are most preferred.
Examples of the analgesic adjuvant include Toki Shukuyakusan, Toki Shikaka Kuretsuoto, or Rokumi Maru Kampo, Meloxicam, Neurotropin, Mecobalamin, or Milnacipran or a salt thereof. It may be a combination.
In addition, as an FMS patient in whom the effect was not obtained even when milnacipran or a salt thereof was administered, an FMS patient administered with 30 mg or less of milnacipran or a salt thereof per day includes 25 mg per day. FMS patients administered the following milnacipran or salts thereof are preferred.

  The present invention also provides a method for treating pain associated with FMS in a subject animal including a human, specifically, by administering an effective amount of elcatonin to a subject patient suffering from pain associated with FMS. A method of treating pain associated with FMS.

The aqueous solution containing elcatonin as an active ingredient is not particularly limited as long as it contains an effective amount of elcatonin. For example, an aqueous solution with an appropriate pH secured is preferable. As the solvent, known buffer solutions such as a citrate buffer solution and an acetate buffer solution can be used, and the pH is preferably 5 to 7, and more preferably pH 5 to 6. These concentrations are preferably 0.05 mmol or more, and more preferably 0.1 mmol or more. Although an upper limit is not specifically limited, Usually, 20 mmol concentration or less, Preferably 1 mmol concentration or less is mentioned.

Specifically, it contains one or more compounds selected from the group consisting of monocarboxylic acids such as acetic acid, lactic acid and L-histidine and / or water-soluble salts thereof, and the concentration thereof is 0.05-20.
Solvents with a millimolar concentration, pH adjusted to 5.0-6.5 and ionic strength μ = 0.01-0.5 (Japanese Patent Laid-Open No. 2-174726), succinic acid, tartaric acid, etc. Containing one or two or more compounds selected from the group consisting of monovalent carboxylic acids and / or water-soluble salts thereof, with a concentration of 0.05 to 20 mmol, a pH of 5.0 to 6.5, and Ionic strength in μ
= Solvent adjusted to 0.01 to 0.5. Moreover, sodium hydroxide, hydrochloric acid, etc. can be used for adjustment of pH as needed. In addition, if necessary, gelatin is added in an amount of 0.
Containing 01-20 w / v%, isotonic agent, procaine hydrochloride, xylocaine hydrochloride,
Surfactants such as benzyl alcohol and phenol, soothing agents, stabilizers, absorption accelerators, preservatives, polysorbates, polyoxyethylene, glycerin, macrogol and the like can be added.
Moreover, as a density | concentration of elcatonin, the thing of 10 units-80 units / mL can be used, for example.

  The FMS therapeutic agent of the present invention includes an FMS therapeutic agent that can be administered in combination with elcatonin and a selective serotonin / noradrenaline reuptake inhibitor. Examples of selective serotonin and noradrenaline reuptake inhibitors being administered in combination with elcatonin and a selective serotonin and noradrenaline reuptake inhibitor, or elcatonin alone, after administration of a selective serotonin and noradrenaline reuptake inhibitor It is preferable to administer a combination of elcatonin and a selective serotonin / noradrenaline reuptake inhibitor after the agent is administered. There is also another embodiment in which it is preferable to administer elcatonin alone after the selective serotonin / noradrenaline reuptake inhibitor is administered.

Examples of pharmaceutical dosage forms suitable for the present invention include sustained release formulations, for example, sustained release formulations by subcutaneous injection, intramuscular injection, intravenous injection or intraperitoneal injection, preferably by subcutaneous injection or intramuscular injection. Examples include sustained-release preparations, infusion preparations, patch preparations, and the like. As a sustained-release preparation by subcutaneous injection, intramuscular injection, intravenous injection or intraperitoneal injection, for example, a poly (D, L-lactide-co-glycolide) polymer as disclosed in JP-T-11-501027 can be used. Examples include those prepared using microspheres using degradable excipients so that elcatonin has the above dosage. As an infusion preparation, the drug in the preparation disclosed in “Japan Clinical, Vol. 59, No. 9, p. 1789-1793, 2001” was replaced with elcatonin, and the formulation was formulated so that elcatonin would have the above dosage. Is exemplified. Examples of the patch preparation include a patch preparation of a type in which a fine needle is provided on the surface to be applied to the skin and the drug oozes out therefrom. For example, for the patch preparation disclosed in JP-T-2004-528900, elcatonin is as described above. What was prescribed so that it might become a dosage is illustrated. However, it goes without saying that the present invention is not limited to these.

The present invention will be described based on examples. The present invention is not limited to the following examples, but the effects of the present invention are sufficiently described by the following examples.
[Formulation example 1] Formulation example of FMS therapeutic agent containing elcatonin 0.544 g of sodium acetate (trihydrate) and 1.8 g of sodium chloride were dissolved in water to obtain a 200 ml solution. Dilute to 200 ml with 0.9% (w / v) sodium chloride solution. To this, 0.72 mL of 0.002N hydrochloric acid is added and mixed to adjust the pH to 5.5 and the ionic strength to 0.15. Elcatonin 1.4 mg can be dissolved in 200 ml of the thus obtained solution to obtain an elcatonin aqueous solution composition.
[Formulation Example 2]
As elcatonin, Elsitonin injection 20S disposable (manufactured by Asahi Kasei Pharma Co., Ltd.) can be used.

[Example 1]
1) Subject: Age 73 years, female gender, height 148.5 cm, weight 48.8 kg
Previous medical history: Visiting internal medicine due to hypertension and insomnia, History of orthopedic surgery going to our hospital since April 21, 2006 due to deformed lumbar spondylosis: Soil for a long time in a plastic house next to the house on the same month 26th During disinfection, there was a complaint that "back pain worsened after exposure to pesticides (chloropicrin)." Since then, the pain gradually increased, and on June 30, the pain began to develop in the neck, trunk, limbs and body.
Physical findings: All 18 tender points by palpation as FMS were positive.
Chinese medicine proof: cold, feet are cold even in summer.
Pulse: Vein (pulse touched only after deep pressure)
Tongue: Light red tooth impression (compression mark by teeth on the margin of the tongue) ± sublingual vein anger-
Abdomen: Chest wrestling (dull pain and tightness in the season)-, lower heart whip (holding and resistance and tenderness in the chin)-, intragastric retention (stagnation of water in the stomach) +, upper and lower umbilicus悸 (beating palpation of the abdominal aorta in the upper and lower navels)-, abdominal skin arrest (a state in which the rectus abdominis is excessively tensioned)-, small abdomen (the abdominal wall easily collapses when the lower abdomen is compressed without help) ) ±, small abdominal stiffness (hard resistance in the lower abdomen, fullness) +, rapid abdominal knot (tenderness in the left iliac fossa) +
Skin is moist, hot and cold on the lower limbs + (high heat and cold)
The blood test showed no abnormal findings.

2) Treatment course: In addition to Western medical treatment, Kampo medicine is widely used in combination, and since May 19 the same year, Toki Sakuyakusan 5g 2+ The prescription was started from 5g / day for 5g.
Although the cold sensation of the lower limbs improved, the hot flashes on the face increased, and the tendency to sleeplessly worsened. From 14 July onwards, meloxicam 10 mg lT + Tokuyaku Yakusan 5g 2 + Rokumaimaru 5g 2 / day was changed to a raw diet. 100 mL + neutrobin 2A + mecobalamin 500 μg 2A / day were administered in combination by intravenous infusion.
Symptoms such as slight fever continued until mid-June and tears often appeared until July. On August 11, the hot flashes on the face and the coolness of the limbs improved at Rokumimaru, but other painful areas improved only slightly.
Although the hot flashes on the face disappeared completely on August 18, the symptoms continued for a period of six months.
Since March 23, 2007, since depression was observed due to long-term pain, milnacipran 15 mg 2 T / day was additionally administered. Thereafter, insomnia and depressive symptoms improved, but pain in the trunk and extremities persisted.
On May 11, the bone density (BMD) was measured to be 76% (YAM), but mild deformation and atrophy of the upper spine were observed from the XP (X-ray photograph) findings (FIG. 2). An intramuscular injection of 20 units / week of elcatonin was started under the diagnosis of osteoporosis. At this time, the VAS (Visua1 Analogue Scale) of 100 mm was 91 mm.
On May 16, VAS improved to 85 mm in the first week after administration of elcatonin.
On May 18, the patient himself stated that “pain has improved. I can sleep better at night”, so administration of elcatonin was continued.
On June 2, VAS improved to 50 mm.
On June 8, the patient himself said, “Pain has improved to about half of the previous level, and the current pain is only on the back,” and the tender point disappeared from 8 places to 10 points. After that, pain did not reach complete remission, but the subjective symptoms were improved by elcatonin intramuscular injection, and improvement in ADL (Activity of Daily Living) was observed. ).
Capture: In the above formula, each notation indicates the following.
“A”: indicates an ampoule.
“T”: indicates a tablet.
"2 for 5g": Meaning that 5g was prescribed twice.

3) Consideration From FIG. 3, VAS could be reduced to 50 mm or less in about 3 weeks after the administration of elcatonin. The test subject was an FMS patient with increased back pain triggered by exposure to pesticides for long-term soil disinfection, but started to receive elcatonin when osteoporosis was confirmed. From the first week after administration, pain was improved not only in the low back pain, but also in the upper limbs and trunk.
In addition, regarding the duration of increase in skin temperature, the effect of increasing temperature began to attenuate from around the fifth day of intramuscular injection, and it was considered that the change in increase in skin temperature coincided with the duration of pain relief.
In this way, administration of elcatonin to intractable FMS pain, which was not effective with an analgesic aid such as neurotropin, alleviates pain other than lower back pain, and greatly improved on VAS. Admitted. Although FMS has not been found as an effective therapeutic method so far, it has been accompanied by long-lasting pain and thus often caused a decrease in ADL. However, it has been found that the therapeutic agent containing elcatonin of the present invention can be sufficiently effective. It was.

  According to the therapeutic agent containing elcatonin of the present invention, refractory FMS can be treated, and in particular, an effect of improving pain can be expected.

It is a figure which shows the recording paper of a VAS measuring method. It is a figure which shows the X-ray photograph of the patient shown in an Example. It is a figure which shows the clinical course of the patient shown in an Example.

Claims (14)

A therapeutic agent for fibromyalgia containing elcatonin as an active ingredient . The therapeutic agent for fibromyalgia according to claim 1, wherein pain at eleven or more tender points is 10 or less. The therapeutic agent for fibromyalgia according to claim 1 or 2, which is injected intramuscularly. The therapeutic agent for fibromyalgia according to any one of claims 1 to 3, for a patient who has osteoporosis. The therapeutic agent for fibromyalgia according to any one of claims 1 to 4, for a patient for whom an effect was not obtained by administration of an analgesic adjuvant. The therapeutic agent for fibromyalgia according to any one of claims 1 to 5 , for improving low back pain. The therapeutic agent for fibromyalgia according to any one of claims 1 to 6 , wherein 5 to 80 units of elcatonin is administered 3 to 3 times or more once a week. The therapeutic agent for fibromyalgia according to any one of claims 1 to 6, wherein 5 to 40 units of elcatonin are administered once a week . The therapeutic agent for fibromyalgia according to any one of claims 1 to 8 , which is administered in combination with a selective serotonin / noradrenaline reuptake inhibitor. The fibromyalgia according to any one of claims 1 to 8 , which is administered in combination with or alone with a selective serotonin / noradrenaline reuptake inhibitor after administration of the selective serotonin / noradrenaline reuptake inhibitor. Therapeutic agent. The therapeutic agent for fibromyalgia according to any one of claims 1 to 8 , wherein a selective serotonin / noradrenaline reuptake inhibitor is blended. The therapeutic agent for fibromyalgia according to any one of claims 9 to 11 , wherein the selective serotonin / noradrenaline reuptake inhibitor is milnacipran or a salt thereof. The therapeutic agent for fibromyalgia according to claim 12 , wherein milnacipran or a salt thereof is administered at 30 mg or more per day. Use of elcatonin for the manufacture of a therapeutic agent for fibromyalgia according to any one of claims 1 to 13 .