ATHENA’s AN-051 FOR REFRACTORY EPILEPSY SHOWS 46% SEIZURE REDUCTION
ATHENA's AN-051 FOR REFRACTORY EPILEPSY SHOWS 46% SEIZURE REDUCTION in a Phase II trial reported by Athena Neurosciences President and CEO John Groom at the Robertson Stephens Medical Conference in New York City Dec. 2. Groom said Athena Neurosciences expects to progress to Phase III studies of the anticonvulsant, also called dezinamide, in 1993. Complete results of the Phase II trial will be presented at the American Epilepsy Society meeting Dec. 14-16 in Seattle. The trial, involving 15 refractory epileptics who were "having seizures routinely," incorporated an "n of one design" in which "each patient acts as their own control," Groom told analysts. Under the trial protocol, each patient "is stabilized and then given periods of placebo followed by periods of drug followed by placebo and so on for three interval periods -- three intervals of placebo and three intervals of drug." In addition to the 46% median decrease in seizure rate for patients when on drug, "47% of these patients had a greater than 50% reduction in seizures," Groom reported. This reduction rate "confirmed an earlier study in nine patients where the seizure rate decline was 39%," Groom said. He called the results of the most recent trial "highly significant" and said that "given the nature and design of this trial, there is little doubt that this is an efficacious drug in refractory seizure." Athena licensed worlwide rights to AN-051 from American Home Products in August 1991. NIH's National Institute of Neurological Disorders and Stroke sponsored the Phase I and Phase II studies of the drug, but Athena will provide funding for the Phase III trial. The company is also planning to conduct further pharmacokinetic and pharmacodynamic studies. Athena said it has held back on implementing the protocol for its Phase III studies of the epilepsy drug in anticipation of the Dec. 14-15 meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee, which will review Carter Wallace's Felbatol (felbamate) and Parke-Davis' Neurontin (gabapentin) for epilepsy ("The Pink Sheet" Nov. 30, In Brief). Athena said the meeting should provide a preview of how the agency views various trial designs for epilepsy compounds. Although other epilepsy compounds are further in development than AN-051, Athena said it believes that the need for an "add-on" epilepsy therapy for refractory patients "should remain about the same" as it is now, even if other drugs are approved. Enrollment of patients for the Phase III trial of AN-021A (tizanidine) for the treatment of spasticity associated with multiple sclerosis "should be completed by the end of this year," Groom said. The first patients began the protocol "this spring" and the entire trial should be concluded "in April or May" of 1993, followed by a NDA filing "in the third quarter of 1993," Groom said. Athena filed an IND for the trial in September 1991. The company also plans to include Phase III data collected by Sandoz in its AN-021A NDA. Sandoz, which licensed the U.S. rights to the drug in April 1991, markets tizanidine in 23 countries as Sirdalud. Groom reported that Athena has enrolled 2,000 patients in its Athena Rx mail-order neurologic drug pharmacy program since May. "Break-even in this business would be about 15,000 to 20,000 patients," he said, a goal the company should reach "by the end of next year." He called the mail-order pharmacy program an "opportunity for capturing patients in the neurology sector" prior to approval of the company's proprietary drugs. Also in May, the company formed a field force of 30 representatives, "which gives us the capacity to deliver 29,000 presentations" a year to neurologists, Groom said. Athena is striving to establish name recognition with neurologists by marketing three multi-source neurologic drugs: Atretol (carbamazepine from Lemmon), Atrofen (baclofen from Zenith), and Atarin (isometheptene mucate, dichloralphenazone and acetaminophen from Nutripharm). Athena will begin marketing carbidopa-levidopa, supplied by Lemmon and another Parkinson's disease product in 1993, Groom said.
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