Palatin to start phase 3 bremelanotide trial in Q1 2007

By Elaine Rigoli

Tampa, Fla., Sept. 27 - Palatin Technologies, Inc. said Wednesday that it will start a phase 3 pivotal trial for bremelanotide in the first quarter of 2007.

The company said it will use a tried-and-true regulatory pathway with two pivotal studies, with parallel as well as flexible dosing, with an expected second-half 2008 filing of a New Drug Application.

The company had previously announced that two phase 2b clinical trials in patients with erectile dysfunction showed bremelanotide, a melanocortin agonist that Palatin and King Pharmaceuticals are jointly developing for the treatment of both male and female sexual dysfunction, met primary endpoints.

A nasally administered drug, bremelanotide is a disposable, one-time use product, according to Carl Spana, president and chief executive officer, who spoke during the UBS 2006 Global Life Sciences Conference in New York.

The biopharmaceutical company engages in the discovery and development of melanocortin-based therapeutics and is based in Cranbury, N.J.

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