FDA Approves Sarafem (Fluoxetine HCl) for Premenstrual Dysphoric Disorder
Interneuron to Receive Milestone Payment and Royalties on Sales
The push to expand indications for leading antidepressants continues. Interneuron Pharmaceuticals Inc. (Lexington, MA) has received U.S. Food and Drug Administration (FDA) approval for Sarafem (fluoxetine hydrochloride) for treating premenstrual dysphoric disorder (PMDD), which is characterized by severe mood and physical symptoms around a woman's menstrual cycle. Under a June 1997 license agreement between Eli Lilly (Indianapolis) and Interneuron, Lilly will provide a milestone payment based on the FDA approval and royalties on future sales of Sarafem.
Sarafem will be marketed by Lilly, which received U.S. and global patent application rights covering the use of fluoxetine for PMDD under its agreement with Interneuron. The agreement is based on technology developed at the Massachusetts Institute of Technology (Cambridge) and licensed by Interneuron, showing that women suffering from mood disorders related to their menstrual cycle can be helped by medications that increase brain serotonin levels.
Sarafem is the first and only prescription medication indicated for PMDD. In clinical studies, women treated with Sarafem experienced statistically significant improvement in mood and physical symptoms, as well as social functioning, compared with women taking placebo. These improvements were demonstrated by the first menstrual cycle on treatment.
Sarafem contains fluoxetine hydrochloride, the same active ingredient found in Prozac. The additional trademark will help with educational efforts for this largely underrecognized disorder while reducing confusion about the differences between depression and PMDD. Sarafem will be available in pharmacies in August 2000.
Interneuron Pharmaceuticals specializes in drugs for central nervous system and cardiovascular disorders. Several of its compounds are in late-stage clinical development.
For more information: Glenn L. Cooper or William B. Boni, Interneuron, 1 Ledgemont Center, 99 Hayden Ave., Lexington, MA 02421. Tel: 781-402-3410.