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ROCHE'S VERSED AND SCHERING'S DORMALIN JOIN LILLY's CESAMET WITH LATE DECEMBER NDA APPROVALS FROM FDA BUT FACE SCHEDULING DELAY FROM DEA BEFORE MARKETING

Executive Summary

Newly approved benzodiazepine products from Roche and Schering face at least a two-month delay before marketing can begin while the Drug Enforcement Administration establishes schedules for the drugs. Both Roche's Versed (midazolam) and Schering's Dormalin (quazepam) were approved by FDA in the last week of December with a recommendation to DEA that they join other marketed benzodiazepine products in Schedule IV under the Controlled Substances Act. However, DEA must make an offical scheduling decsion before the drugs can be marketed. The procedure for establishing drug schedules requires that DEA publish a proposed schedule in the Federal Register and then allow a period to evaluate comments received on the proposal. A sixty day period is common. The Roche and Schering products are part of a mini logjam of FDA approved products which are awaiting scheduling decisions by DEA. Lilly's Cesamet (nabilone), approved Dec. 27, and Unimed's Marinol (dronabinol), approved last June, are also being reviewed by DEA. Both drugs, approved for use as antiemetics in patients receiving cancer chemotherapy, are cannabinoid type drugs which the firms say are suited for classification in Schedule II or III. Versed Will Be Co-marketed By Roche And DuPont; Roche Is Getting Development Rights To Antiviral The delays in getting FDA-approved Rx drugs through the appropriate DEA scheduling decisions presumably reflects a lower priority at the Justice agency for routine administrative action related to the legitimate drug industry. The benzodiazepine products in particular do not appear to present any major scheduling issues. Roche's Versed is a fast acting injectable benzodiazepine approved for use in sedation prior to surgery. Approved labeling lists three specific indications: (1) "intramuscularly for preoperative sedation and to impair memory of peri-operative events;" (2) "intravenously as an agent for conscious sedation prior to short diagnostic or endoscopic procedures . . . either alone or with a narcotic;" and (3) "intravenously for induction of general anesthesia, before administration of other anesthetic agents." The labeling adds that Versed "can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthersia) for short surgical procedures: longer procedures have not been studied." In a bold print warning, the package insert instructs that "prior to the intravenous administration of Versed in any dose, the immediate availability of oxygen and resuscitative equipment for the maintenance of a patient airway and support of ventilation should be ensured." Roche filed its NDA for Versed in December 1982, and the drug reached the approvable stage on Nov. 8. At the December clinical meeting of the American Society of Hospital Pharmacists, University of Wisconsin School of Pharmacy Asst. Dean C. A. Bond said: Versed's "onset of action is very fast . . . compared with other agents in that class." Bond added that the drug "has a relatively short half-life of about two hours -- bioavailability being relatively high" ("The Pink Sheet" Dec. 16, T&G-1). The drug will be co-marketed by Roche and DuPont under a trade-off agreement in which Roche will get worldwide marketing rights to DuPont's antiviral rimantadine, which is being investigated as a treatment for influenza. For Roche, the Versed arrangement appears to be an inverse image of the tactic it used with Glaxo's Zantac. In that case, Roche made its sales force available for co-marketing to keep a new product flow going while waiting for its own pipeline products. Now that Roche has a substantial number of products of its own entering the market, it will share marketing of Versed with DuPont to gain access to an antiviral which could reach the market by the end of the decade. DuPont is trading a potential product in the future for something for its hospital salesforce right now. Schering's Dormalin, approved by FDA on Dec. 27, has been under review at the agency since April 1982. The drug is indicated "for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakenings." The label notes that "the effectiveness of quazepam has been established in placebo controlled clinical studies of five nights duration in acute and chronic insomnia. The sustained effectiveness of quazepam has been established in chronic insomnia in a sleep laboratory . . . study of 28 nights duration." Speaking to security analysts in December, Schering President Richard Kogan maintained that quazepam has two advantages that distinguish it from other sleep products: it does not result in rebound insomnia when use is discontinued, and it is highly specific for one type of brain receptor ("The Pink Sheet" Dec. 9, p 10). FDA approved labeling states that "no transient sleep disturbance, such as 'rebound insomnia,' was observed after withdrawal of the drug in sleep laboratory studies in 12 patients." In its approval letter to Schering, FDA noted that the firm is required to conduct two post-approval studies and submit new information within 12 to 18 months. One study is a pharmacologic investigation and the other is a "clinical study to evaluate the relationship between age and dose for quazepam." Schering said initial promotion of the product will be to selected physicians to "familiarize them with its novel properties prior to full-scale commercialization."

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