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BRISTOL-MYERS SQUIBB's STADOL NS TRANSNASAL ANALGESIC APPROVED

Executive Summary

BRISTOL-MYERS SQUIBB's STADOL NS TRANSNASAL ANALGESIC APPROVED by FDA on Dec. 12 for the "management of pain when the use of an opioid analgesic is appropriate," BMS announced Dec. 17. Stadol NS, a nasally-administered form of the company's butorphanol tartrate injectable analgesic that has been marketed for more than 13 years, has been shown in clinical trials to be effective "in a variety of pain models," the company said, "including postoperative pain and migraine headache pain." The company also has looked at the drug for pain associated with dental surgery. Stadol NS was given a "3C" (new formulation of existing drug with little or no therapeutic gain) classification by FDA. The mixed agonist/antagonist opioid analgesic will be administered via metered-dose nasal spray. Approved dosing is 1 mg, which is equal to one spray in one nostril. Initial dosing may be followed by 1 mg within 60-90 minutes and 1 mg again every three to four hours as needed. Shipments are slated to begin in early 1992, BMS said. The company has selected its women's health care products unit, Mead Johnson Labs to detail Stadol NS. The unit has a sales force of 320 and recently has obtained the rights to a vaginal fungicide from Fujisawa. The injectable analgesic has been indicated for moderate to severe pain, supplements to anesthesia and obstetrical analgesia. Extension of acceptable uses to self-administration for post- operative pain or migraine could add substantially to the product's market potential. Mead Johnson may get a chance to ride the increased interest in migraine treatment arising out of the development effort for serotonin receptor agonists. Glaxo's pending approval for Imitrex (injectable sumatriptan) is expected to create a surge of interest in new migraine treatments. Bristol-Myers Squibb filed the NDA for the nasal formulation of butorphanol in April 1989 specifically for the treatment of migraine. The drug received an "NDA Day" at FDA on June 24, 1991 with the Pilot Drug Evaluation Staff. On Feb. 4, 1991, FDA's Drug Abuse Advisory Committee recommended that BMS use post-marketing surveillance to study the abuse potential of the nasal delivery form of Stadol ("The Pink Sheet" Feb. 11, p. 10). FDA advisory committees have looked at the abuse potential of butorphanol seven times previously. Neither injectable Stadol nor Stadol NS is scheduled for Drug Enforcement Agency control, and BMS says it feels nasal butorphanol has shown a very low incidence of abuse liability. Mead Johnson Labs markets Estrace (estradiol) tablet and cream estrogen replacement therapy; Ovcon norethindrone 1 mg/ethinyl estradiol 0.035 mg 28-day oral contraceptive; and Natalins/Rx prenatal vitamins. The unit will begin detailing Vagistat-1 (tioconazole) vaginal antifungal in the first quarter of 1992. BMS licensed the product from Fujisawa Pharmaceutical Company, which had marketed the single-dose prescription treatment for vulvovaginal candidiasis under the Vagistat tradename since October 1989, after the company obtained the U.S. marketing rights from Pfizer in May 1989.

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