An experimental treatment for low or absent sexual desire in women could be on the pharmacy shelves as early as 2018, based on positive results from two Phase 3 trials.
Palatin Technologies announced Tuesday that subjects taking bremelanotide had shown a statistically significant increase in desire and a subsequent reduction in distress, the stated aims for its so-called Reconnect Studies.
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“We could not be more pleased with the bremelanotide Phase 3 co-primary endpoint results,” said Carl Spana, president and CEO of Palatin, in the company’s news release.
Bremelanotide’s progress is shadowed by last year’s approval of the controversial “pink viagra” pill Addyi (flibanserin), which was twice rejected by the FDA.
Developed by Sprout Pharmaceuticals and later sold to Valeant for $1 billion, Addyi became heavily politicized.
Proponents fought for approval based on the belief that women’s should have at least one equivalent to men’s array of therapeutic options. The medical community countered this argument, saying the science simply wasn’t there. Addyi was ultimately approved but sales have been almost non-existent.
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In the fallout, the FDA seems to have reflected on its processes for approving treatments for sexual dysfunction in women. In late October the agency amended its protocol, creating a clearer path to the clinic for what is a very subjective condition.
In medical terms the condition is known as hypoactive sexual desire disorder (HSDD), a diagnosis characterized by a lack or absence of sexual desire, as judged by a clinician. Palatin states on its website that it affects approximately one in 10 women. It can be acquired, or life-long. All other possible causes, such as medications, illegal drugs, and mental disorders must be ruled out.
Importantly, the diagnostic criteria for HSDD also state that the condition must negatively impact the patient’s life. Measures of ‘distress’ were therefore included as a primary endpoint for Palatin’s two randomized, double-blinded, placebo-controlled Phase 3 studies.
“The distress component of HSDD reflects the profound negative impact that this condition can have on women’s self-image, relationships and quality of life well outside the bedroom,” said clinical investigator Sheryl A. Kingsberg, Prof., reproductive biology at Case Western Reserve University School of Medicine. “In the Phase 3 trials we saw significant reduction in distress with use of bremelanotide.”
As per the study protocol, patients self-administered either 1.75 mg of bremelanotide or placebo as needed in anticipation of sexual activity.
Therein lies a significant setback for the drugs marketability. A Palatin representative confirmed that its ‘subcutaneous treatments’ are automated injections, typically administered through the thigh.
Carrying and using injections doesn’t scream ‘romance,’ but it could be worse. The injections are stable at room temperature, which means they don’t need to be refrigerated at all times. The treatment takes effect in around 30 minutes and lasts up to eight hours.
Palatin noted that bremelanotide appears to be well tolerated. The most frequent adverse event was nausea, which was typically mild.
With these positive results, a new drug application (NDA) submission to the FDA is scheduled for mid-2017, which could see the drug hit the shelves the following year.
Whether Palatin or another company takes it to the finish line remains to be seen. Fortune reported Wednesday that Palatin was believed to be shopping around for a buyer to take the drug to market.
Photo: Diane Diederich, Getty Images
