LILLY's PERMAX ACCEPTED AS ADJUNCT TO LEVODOPA in the treatment of Parkinson's disease by FDA's Peripheral and Central Nervous System Drugs Advisory Committee. In a unanimous decision at its May 19 meeting, the panel agreed that Lilly's multicenter Permax (pergolide mesylate) trial establishes safety and efficacy of the agent as adjunctive therapy for Parkinson's disease. The committee recommended approval based on a six-month, 16-center trial. Although FDA generally requires two independent clinical trials to support approval of a new drug, FDA Neuropharmacologic Drugs Division Director Paul Leber, MD, told the committee that in Permax's case, the agency decided that the single multicenter study is enough, because it provides "a persuasive body of evidence" and the results from the separate centers collaborate. Reporting results of the randomized, double-blind, placebo-controlled study, FDA medical review officer Jaenth Rouzer-Kammeyer, MD, stated that "in subjects experiencing a variable response to levodopa, pergolide administered in combination with levodopa demonstrates a levodopa clearing effect at the same time that it improves the overall Parkinson disability." The trial, which was initiated in September 1983, compared pergolide with placebo in 376 Parkinson's patients with idiopathic disease. Patients had to be of mild-to-moderate disability with less than optimal response to levodopa therapy. Patients received single daily doses of .05 mg pergolide or placebo for the first two days, and then the dose was gradually increased to .75 mg b.i.d. over the next 2 weeks, Rouzer-Kammeyer said. For the remainder of the study, the daily dosage could be titrated by .25 mg until an optimal dosage or a maximum dosage of 5 mg had been reached. "Sinemet dosage was to remain constant during the first two weeks of the study and then could be lowered during weeks 3 through 26," she noted. Sinemet's total daily dosage could not be increased during those weeks unless patients had received the maximum dose Permax for two weeks and were not sufficiently controlled, Rouzer-Kammeyer said. "Pergolide patients had a mean decrease in levodopa of 235 mg compared to 61 mg on placebo."
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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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