Unimed's anti-emetic Marinol (dronabinol) will be the first drug marketed for anorexia associated with weight loss in AIDS patients following the approval of the firm's supplemental NDA on Dec. 22. The supplemental NDA moved quickly through FDA. A synthetic version of the active ingredient in marijuana (THC), Marinol was first approved in 1985 as second-line treatment of nausea and vomiting related to cancer chemotherapy. Unimed filed for the AIDS-related weight loss indication in August of this year, and the supplemental NDA was the subject of a Dec. 2 "NDA Day" at FDA ("The Pink Sheet" Dec. 7, In Brief). The Boehringer Ingelheim subsidiary Roxane Labs copromotes Marinol in the U.S. and is the exclusive U.S. distributor for the product. Sales of Marinol in the year ended Sept. 30, 1992 were approximately $5.2 mil., Unimed said, which was split evenly between the two firms. Marinol sales in FY 1991 were about $3.4 mil. Roxane said that for the AIDS-related indication dronabinol will be available in one-month prescription prepack bottles of 60 2.5 mg capsules priced at $120 wholesale. The company estimated that this price will translate to a retail cost of $150 to $180 per month. For chemotherapy-related nausea and vomiting, dronabinol is marketed in bottles of 25 capsules. Roxane noted that "the capsules are priced the same for the existing indication for anti- nausea in cancer chemotherapy patients as for anorexia in patients with AIDS." For the treatment of AIDS-related anorexia, daily dosage is one capsule before lunch and another before dinner. Unimed said the new 60-capsule packages will be available in the first quarter of 1993 but that Marinol will be promoted for the new indication earlier. Roxane has established a patient assistance program "to help cover the costs of Marinol for indigent AIDS patients whose physicians prescribe the drug, but who cannot afford the cost." People with AIDS who have no insurance coverage, annual incomes below $25,000 if single, or $40,000 with dependents may be eligible for the program. Physicians must call Roxane to establish the eligibility of their patients. The supplemental NDA was based on data from a randomized, double-blind, placebo-controlled clinical trial involving 139 patients. "Patients with weight loss participating in clinical trials with Marinol experienced increased appetite after four weeks of treatment," Roxane said. Phase III trials of dronabinol for the new indication were begun in 1990. Initial clinical studies were prompted by anecdotal reports from people with AIDS who found marijuana improved their appetites, FDA said.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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