Apricus Biosciences Seeking Global Partner Following FDA Approval of Addyi

Apricus Biosciences (NASDAQ:APRI) has reaffirmed its intention to find a global development partner for Femprox, its treatment for female sexual interest/arousal disorder (FSIAD).
The company’s announcement came after the news that Addyi, Sprout Pharmaceuticals’ female libido-enhancing drug, has gained approval from the US Food and Drug Administration (FDA).

FDA approves Sprout Pharmaceuticals’ Addyi

The FDA’s approval of Addyi came Tuesday. The drug, whose generic name is flibanserin, is designed to increase sexual desire in premenopausal women with generalized hypoactive sexual desire disorder (HSDD) by boosting brain chemical levels. According to the BBC, the pill was previously rejected twice by the FDA due to its lack of effectiveness and side effects, including nausea, dizziness and fainting.
Sprout Pharmaceuticals’ press release explains that the FDA’s recent approval is largely premised upon three North American Phase 3 clinical trials during which patients who took Addyi “demonstrated improvements in desire for sex, reducing distress from the loss of sexual desire and increasing the number of satisfying sexual events.”
However, some critics of Addyi remain skeptical of its value. Forbes reported that the drug still has severe side effects, including sudden fainting and blood pressure drops and interactions with alcohol. John LaMattina, former head of R&D at Pfizer (NYSE:PFE), also foresees challenges with the drug’s pricing, which is competitive with erectile dysfunction drugs like Pfizer’s Viagra and Eli Lilly’s (NYSE:LLY) Cialis. But unlike those treatments, which are taken on demand, the Addyi pill must be taken every day. According to LaMattina, insurers may be reluctant to cover such a costly drug, which produces only modest improvements for most women with HSDD.
Nonetheless, the drug does have some outspoken supporters. According to MedCity news, Dr. Irwin Goldstein, president of the Institute for Sexual Medicine, has likened the drug’s approval to a “nuclear bomb [exploding] in women’s sexual health.”

Precipitous timing

As mentioned, the FDA’s approval of Addyi has given Apricus new optimism concerning the success of Femprox, its FSIAD drug. Apricus’ CEO, Richard Pascoe, explained in a press release that “given the recent FDA approval of Sprout Pharmaceuticals, Inc.’s flibanserin for female sexual dysfunction, Apricus now believes that a potential regulatory path exists in the U.S. for Femprox.” Pascoe thus plans to “immediately initiate a disciplined partnering process to identify potential licensees for the global development and commercialization rights for Femprox with the goal of maximizing our return on investment for the potential benefit of shareholders.”
Investors responded positively to this news, with Apricus’ share price increasing by 7.89 percent over the course of the day to reach $1.23 by market close.
What is Femprox?
Femprox is a 0.4 percent alprostadil formulation that is delivered using Apricus’ proprietary drug delivery technology, Dodecyl 2-(N, N dimethylamino)-propionate (DDAIP). Apricus has completed nine clinical studies for Femprox. Notably, the company has completed a 98-subject Phase II study in the US, and a near 400-subject proof-of-concept clinical trial in China.
The cream is intended to treat FSIAD through topical application. It works by exerting a local relaxant effect on vulvar and clitoral blood vessels in women, which results in heightened blood flow to the area. The ensuing lubrication and increase in sensory feedback is believed to increase arousal in women suffering from the disorder.
 

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