Sixteen years ago, Pfizer Inc. created a stir — and a $2 billion market — when it introduced Viagra to treat male sexual dysfunction. Since then, more than 20 drugs have been approved for some form of the condition.
The number approved for female sexual dysfunction? Zero. Palatin Technologies, a biopharmaceutical company based in Cranbury, may soon change that.
The company is creating Bremelanotide, or BMT, a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone).
Where Viagra and its competitors increase blood flow to the genital region, that approach has proven unsuccessful for women with female sexual dysfunction, or FSD. Instead, BMT works on portions of the brain related to sexual arousal. The drug is administered subcutaneously and is taken on-demand with an eight- to 10-hour “window of opportunity.”
For now, it is targeted toward pre-menopausal women, though the market may expand to post-menopausal women as well.
Palatin is currently preparing for Phase III trials, in which the drug will be tested on up to 1,500 women — a significant step closer to FDA approval. If all goes well, approval will be granted in the first half of 2017. BMT will hit the market no earlier than 2018.
And what a market it is. Nearly one in two non-menopausal women ages 30 to 50 say they have experienced low sexual desire at some point, and 61 percent have felt distressed by it, according to a recent national study conducted by Palatin and Healthy Women, a nonprofit health information source.
“We estimate that peak sales for this product, about four to five years post-commercialization, will be in the $800 million range in the U.S.,” said Stephen Wills, the CFO and COO of Palatin. “Globally, if things go well, we're looking at $1.5 billion.”
PREPARING THE MARKET
Clinical trials and, eventually, commercialization, cost a lot of money, which is why Palatin is now in active discussions with potential partners to assist with BMT's next steps.
Breaking new ground carries additional burdens.
“We've had to educate a lot of different groups in this area,” Wills said.
One group is the FDA itself.
“When studying male functions, there's a simple end point that can be seen and measured,” Wills said. “With women, it's much more complicated. We have to use what's called PRO — for patient-reported outcomes — questionnaires to measure satisfying sexual events and come up with a sexual function index score.”
Palatin had intensive discussions with the FDA in order to get clear guidance and agreed-on end points for trials.
Palatin also has contacted insurers to get their take on whether BMT, if approved, is likely to be covered in the same way Viagra often is.
“The feedback we've received indicates that there's not a circumstance where females would be treated any less than the male side in this area,” Wills said.
THE FINAL STEP
Last but definitely not least, there's education to be done for the public.
“I want to be clear: With BMT, we are trying to get patients back to their normal state of desire, which they've experienced in the past,” Wills said. “Patients feel increased desire and arousal, but this is not an uncontrolled behavioral modification.”
Whatever you do, don't call BMT a “lifestyle” drug.
“FSD is not a casual issue,” Wills said. “Women we have interviewed are distraught about this condition. It's affecting their relationships and self-esteem.
“BMT is not like a cancer drug, but we what we are treating is absolutely a real condition.”
Lee Lusardi Connor is a freelance writer based in Morris Plains.