Ann Arbor biotech firm QuatRx Pharmaceuticals is on track to submit a federal application for approval of its post-menopausal sex drug by early 2010, company officials announced today.

Securing the Food and Drug Administration’s approval for Ophena would prove to be a significant accomplishment matched only by a few biotech companies every year. The FDA approves about 10 to 20 new drugs annually.

QuatRx reported promising efficacy and safety results from a crucial stage of its second Phase 3 clinical trial for Ophena. Company officials said the latest results confirm similar outcomes produced in its first Phase 3 trial.

“We still need to get all our data in,” QuatRx senior business development director Julia Owens said this morning. “We’re not quite there. But we’re very encouraged.”

The drug would treat a condition called post-menopausal vulvovaginal atrophy, which causes dryness or irritation that can make sexual activity painful. The drug could also be used by women who experience such symptoms but aren't sexually active.

QuatRx officials have been hesitant to describe Ophena as a female version of Viagra, a male sexual dysfunction drug with a market north of $1.8 billion. But the potential market for the drug is enormous.

Some 40 percent of American women over age 40 report symptoms of vaginal atrophy. Ophena is a non-estrogen therapy, which stands in contrast to most vaginal atrophy treatments on the market.

Stephen Rapundalo, executive director of Ann Arbor-based MichBio, the state’s life sciences association, said QuatRx has to surmount the difficult final stages of the regulatory pathway.

But he said the firm has a credible chance of getting its drug approved.

“Anytime you’re seriously considering an NDA (new drug application), it is a significant milestone, because there’s obviously been a lot of diligence that’s gone into simply reaching that point,” Rapundalo said. “I think the fact that they’re poised to do that is really a testament to QuatRx’s leadership and expertise in executing a very complicated clinical development plan.”

The company’s latest Phase 3 trial involves 919 patients at 116 sites throughout the U.S. QuatRx is simultaneously approaching completion of an independent long-term safety study that could be critical to the future of the drug.

QuatRx’s latest results come about two years after the company secured $44 million in private capital that has enabled the firm to navigate the economic crisis smoothly.

If the firm secures approval for Ophena, it would have to add jobs to market the drug itself, or sign a licensing agreement with a major pharmaceutical firm to do so. QuatRx has about 20 employees apiece at its Ann Arbor and Finland offices.

Other biotech companies have added between 60 and 200 employees to market similar therapies, Owens said. But she emphasized that the company had not decided how to market the drug.

“We’re really in a stage right now where we’re defining what the best path to market this drug is,” she said. “Everything’s possible right now.”

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