Palatin, King complete enrollment in two phase 2b trials of bremelanotide in erectile dysfunction patients

By E. Janene Geiss

Philadelphia, May 4 - Palatin Technologies, Inc. and King Pharmaceuticals, Inc. said Thursday that the companies have completed enrollment in two phase 2b clinical trials of bremelanotide in patients with erectile dysfunction.

Bremelanotide is a melanocortin agonist that Palatin and King are jointly developing for the treatment of both male and female sexual dysfunction, according to a company news release.

The primary objective of these two dose-ranging clinical trials is to identify safe and efficacious doses for evaluation in phase 3 pivotal trials slated to begin in the first quarter of 2007, officials said.

The two clinical trials are double-blind, placebo-controlled trials that entail a one-month run-in period and a three-month treatment period. The primary endpoint for both studies is the change in the erectile function domain of the International Index of Erectile Function from baseline at the end of the three-month treatment period, officials said.

The first phase 2b clinical trial is evaluating the safety and efficacy of bremelanotide in about 560 non-diabetic patients suffering from mild to severe erectile dysfunction. The second clinical trial is similarly evaluating 265 diabetic patients also suffering from mild to severe dysfunction.

Bremelanotide is the first compound in a new drug class called melanocortin receptor agonists under development to treat sexual dysfunction. The mechanism of action of bremelanotide may offer important benefits over currently available products for the treatment of erectile dysfunction because it acts on the pathway that controls sexual function without acting directly on the vascular system, officials said.

Clinical data indicates that bremelanotide may be effective in treating a broad range of patients suffering from ED. The nasal formulation of bremelanotide currently under development is as convenient as oral treatments, is more patient-friendly than invasive treatments for erectile dysfunction, such as injections and trans-urethral pellets, and appears to result in a rapid onset of action.

Although the current erectile dysfunction market is primarily served by PDE-5 inhibitors that target the vascular system, a substantial unmet medical need for alternative sexual dysfunction therapies exists because many patients are contraindicated for, or non-responsive to, PDE-5 inhibitors.

Palatin is a Cranberry, N.J., biopharmaceutical company primarily engaged in the development of melanocortin-based therapeutics.

King, based in Bristol, Tenn., is a vertically integrated branded pharmaceutical company.

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