Trimel Pharmaceuticals is hoping its drug, a nasal spray called Tefina, will do for women what Viagra did for men. (Getty)
Pfizer Inc. created a multi-billion-dollar market when it launched the sexual-performance-enhancing drug Viagra in 1998. Ever since, drug companies have been trying to repeat that men-only success with a treatment for women. But getting a product to market has proven exceedingly difficult. Still, Trimel Pharmaceuticals in Mississauga, Ont., which counts Biovail founder Eugene Melnyk as its biggest shareholder, isn’t turned off by the failures of others. “If our own trials are positive, I have the impression that we’re going to be plastered all over the place,” says CEO Tom Rossi.
That’s a big “if.” Late last year, the U.S. Food and Drug Administration rejected Sprout Pharmaceuticals’ treatment for hyposexual desire disorder (HSDD) in women—in simple terms, a lack of sexual desire—because it wasn’t convinced of the benefits. Sprout joins a long list of failed contenders that includes Pfizer, which gave up in 2004. Rossi says Trimel’s product, called Tefina, differs in important ways from the other attempts. Tefina, which is meant to be squirted up the nostrils before a “planned sexual event,” is a testosterone-based gel whereas Sprout’s drug, flibanserin, started as an antidepressant. Testosterone has been shown to elicit a sexual response in women, Rossi says. A few years ago, actress Jane Fonda enthused about using testosterone treatments to boost her libido. Some women already partake in the off-label use of gels designed to treat low testosterone in men—a risky move since those gels can cause acne and unwanted facial hair in the wrong dosages. Tefina is formulated for women, though. It’s also taken on an as-needed basis, not every single day like flibanserin, which could help lessen concerns around safety.
Still, testosterone treatments are far from a sure thing. U.S. company BioSante Pharmaceuticals applied to the FDA with a similar product in 2011, with no success. The results showed it was no more effective than a placebo. Rossi counters that Tefina isn’t targeting HSDD like past candidates, but a different condition called anorgasmia, defined as persistent difficulty in achieving orgasm. Whereas HSDD trials tend to be subjective—a survey question might include, “Did you experience more desire?”—whether or not Tefina worked is considerably less open to interpretation, Rossi says, and that could lead to stronger data.
Trimel expects to complete Phase 2 trials in the first half of the year. If all goes well, the company can move to Phase 3 and be on the market by 2018. The company that gets to market first has a lot to gain. “It could be huge,” says an analyst who follows Trimel but isn’t authorized to speak on the record. “It could be another Viagra.” Yet some analysts put no value on Tefina. The prospects are uncertain, and it’s tough to judge the potential market size when no other medical treatment exists.
The fate of Tefina could also depend on what happens with Trimel’s lead product, a gel for low testosterone in men, called CompleoTRT. The FDA could approve the treatment as soon as February. But if the regulator demands more research be conducted first, Trimel would have to divert cash to that task, according to an analyst report from Bloom Burton & Co. That could put Tefina on hold, unless Trimel finds a partner to fund more work on it.
Rossi insists Tefina’s development is not contingent on CompleoTRT. Its future, he says, will be a lot clearer once the Phase 2 study is completed. But he’s optimistic. “We did a very small trial in the Netherlands,” Rossi says of the company’s first trial. “Twelve of the 45 women got orgasms. So we’ve seen something.”
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