No news on research data but I saw this on
http://www.businessweek.comQuote:
Lundbeck, Facing Lexapro Generics, Turns to Anti-Alcoholism Drug
H. Lundbeck A/S, whose best-selling antidepressant Lexapro loses patent protection in the U.S. this year, is in talks with potential marketing partners for an experimental alcoholism drug that wouldn't require patients to first give up drinking, Chief Executive Officer Ulf Wiinberg said.
The loss of the patent opens up Lundbeck, the Danish developer of drugs for depression and neurological illnesses, to generics competition.
The company has received has “many inquiries” into the anti-alcoholism product, called nalmefene, Wiinberg said. The Valby-based company aims to sell the medicine in Europe to general practitioners, and its sales force now primarily deals with specialists in central nervous system diseases.
“We're not going to hire 2,000 people,” Wiinberg said yesterday by phone.
Lundbeck has research under way in the last phase of testing usually required to seek regulatory approval. The company said it expects to apply for marketing permission in the second half of next year.
Patients who want to reduce their alcohol consumption would take the pill before they expect to begin drinking. The approach contradicts decades of treatment that requires alcoholics to abstain completely. Lundbeck will have to change both health- care providers' and consumers' behavior, Wiinberg said.
“We will put significant resources into this,” he said.
What's interesting about this is that when DuPont launched Revia in the US in 1995 the sales force could only market it to specialists and only as an adjunct to comprehensive alcohol treatment. DuPont may or may not have known that naltrexone worked better in a targeted approach but it didn't matter because the FDA would not let them market it that way. This is why Revia was given with the instructions not to drink before taking it. Fast forward to present times and what Lundbeck is trying to achieve is approval of oral nalmefene specifically for targeted use. Presumably if their results pan out and they get approval their marketing efforts to the general practicioner will be essentially the Sinclair Method.