Biotech firm Palatin, which is developing a “female Viagra” drug, is newly optimistic this month following a successful late-stage clinical trial of bremelanotide.

The “Reconnect” clinical trial included around 1,000 subjects and lasted six months. Palatin said the trial met its predetermined clinical endpoints, with women who used it reporting having more sexual desire and less distress associated with sex, but not having sex more frequently versus a placebo. In the days following the trail, Palatin stock has risen from 50 cents to about 75 cents as of press time, and Reuters reported the company was shopping itself around for a sale.

Palatin, a 20-person company headquartered on Cedarbrook Drive in Cranbury, is developing bremelanotide as a treatment for women who suffer from low sexual desire. Each dose of the drug lasts about an hour, and is delivered in a shot to the thigh or abdomen via an auto-injector that the patient can use on herself. (U.S. 1, July 15, 2015.)

Last year women were out of luck when it came to pharmaceutical treatments for sexual dysfunction. But in early 2015, the FDA approved the first ever drug for “hypoactive sexual desire disorder.” Addyi, the first drug approved and so far the only competitor to bremelanotide, is a pill that has to be taken regularly to be effective and comes with the restriction of not being able to drink alcohol.

The FDA decision to approve Addyi opened the door for Palatin’s product to treat the same problem, but with a different set of trade-offs. The decision was not without controversy, as critics pointed out that studies so far have shown only modest benefits for both drugs, and some questioned whether HSDD was an actual medical condition, or whether it was best viewed as a relationship or psychological problem.

Bremelanotide could be marketed as early as next year. There is no trade name for the drug yet. Its history goes back to the 1990s when researchers at the University of Arizona tested the peptide on college students hoping it would cause skin tanning and increase resistance to cancer-causing ultraviolet rays. Instead, the drug caused “spontaneous erectile activity” in male subjects and was explored as a sexual dysfunction treatment.

Palatin estimates the U.S. market for its drug at about 11 million people and potentially $1.3 billion in annual sales.

Meanwhile, Addyi, which is made by Valeant Pharmaceuticals, has been struggling. The company had hoped to sell about $100 to $150 million in its debut year, but in March Forbes reported Addyi was selling at just $11 million a year and that Valeant had laid off most of the Addyi sales force.

Palatin Technologies Inc. (PTN), 4B Cedar Brook Drive, Cedar Brook Corporate Center, Cranbury 08512. 609-495-2200. Carl Spana PhD, president & CEO. www.palatin.com.

Facebook Comments