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Executive Summary

CIBA-GEIGY's ANAFRANIL: PATIENT POPULATION OF UP TO 5 MIL. may benefit from use of the obsessive compulsive disorder (OCD) therapy. In a Jan. 9 release announcing approval of the drug, Ciba-Geigy said that "as many as five mil. Americans may suffer from OCD, which causes people to experience recurring thoughts (obsessions) and act out meaningless ritualistic behaviors (compulsions) such as cleaning, checking and counting, often to the degree that they are virtual prisoners of their condition." As the first drug therapy for OCD, however, the expected patient population for Anafranil is difficult to pinpoint. The American Psychiatric Association's most recent estimates put the American OCD population at "over four mil." The National Institute of Mental Health estimates that 1.5% of the U.S. population, or 2.5 mil. Americans are affected by the disorder based on a 1980-1984 survey. In addition, although labeling for the drug recommends use in patients that meet strict criteria for OCD, the drug might be used by patients with less severe symptoms. On the other hand, Ciba-Geigy may be faced with the challenge of marketing a drug for a disease that is not well recognized by patients. Anafranil (clomipramine) was approved during FDA's year-end approval rush, on Dec. 29 ("The Pink Sheet" Jan. 1, p. 17). The drug received FDA's "1A" rating, designating a new molecular entity with important therapeutic gain. The approval was highlighted by HHS in a Jan. 9 release. Anafranil labeling is carefully worded to limit use of the drug to patients who meet DSM III-r (Diagnostic and Statistic Manual) criteria for OCD. Labeling states that Anafranil is "indicated for the treatment of obsessions and compulsions in patients with OCD. The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM III-R diagnosis of OCD." * In clinical trials, OCD patients treated with clomipramine had 35%-42% improvement in symptoms (as measured by the Yale-Brown OCD Scale), while placebo-treated patients exhibited no change. Labeling of the drug follows FDA's Psychopharmacological Drugs Advisory Committee's recommendation that the maximum daily dose be limited to 250 mg/day. The committee, which unanimously recommended approval of clomipramine at its Dec. 1 meeting, suggested that use be limited to 250 mg/day because of concerns that greater adverse effects might be seen with higher doses ("The Pink Sheet" Dec. 4, p. 3). The most serious adverse event seen with clomipramine was seizure, which occurred in 0.7% of the approximately 3,500 patients studied in the U.S., with a cumulative rate of 1.5% at one year. Ciba-Geigy expects to have pharmacies stocked with clomipramine in mid-to-late February. In the meantime, the firm will be sending "all pharmacies" initial stock of 12 caps of each dosage size (25, 50 and 75 mg). Average wholesale price for the product is $59.95 for 100 25 mg caps, $82 for 100 50 mg caps, and $110 for 100 75 mg caps. Anafranil is the fifth Treatment IND drug to clear the agency. The agent has been made available to patients under the pre-approval, expanded access program since the summer of 1988. Approximately 2,000 patients have received the drug under the Treatment IND. Ciba-Geigy notified the Treatment IND physicians of the approval on Jan. 2 and instructed them to bring patients in for a final visit between Feb. 15 and March 15, at which time they will be given a prescription for the product.

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