Health Canada has accepted the Apricus Biosciences Inc.'s request for a Pre-New Drug Submission (Pre-NDS) meeting to obtain regulatory guidance from the agency for Femprox, its topical alprostadil cream for the treatment of female sexual arousal disorder (FSAD). The meeting is scheduled to take place on July 17, 2012.
Apricus Bio expects to obtain feedback from Health Canada regarding the suitability of their existing clinical, preclinical, and chemistry data to support a New Drug Submission (NDS) in Canada.
Femprox is a topically applied formulation of 0.4 per cent alprostadil delivered using dodecyl 2-(N, N dimethylamino)-propionate hydrochloride (DDAIP HCl) or NexACT, Apricus Bio's proprietary drug delivery technology. To the Company's current belief, Femprox is further along in development than any other product for FSAD and is the only product candidate to have successfully completed an approximately 400 subject phase III clinical trial, a trial which achieved statistical significance in both its primary and secondary endpoints.
“We look forward to working with Health Canada and gaining clarity regarding the development path forward for Femprox in Canada,” said Bassam Damaj, PhD, president and chief executive officer of Apricus Bio. “We believe Femprox is a unique treatment option for FSAD, not only because of its topical delivery, local mechanism of action, and its safety profile, but also because of its high response rate. Upon completion of this meeting we will be one step closer to filing in the Canadian market and bringing a new treatment option to women suffering from FSAD.”
Femprox is a 0.4 per cent alprostadil cream intended for the treatment of FSAD. To date, Apricus Bio has completed nine clinical studies with Femprox, including one, 98-patient phase II study in the US and an approximately 400 subject phase III study in China. To the Company's knowledge, no product is currently approved to treat FSAD, a persistent or recurring inability to attain, or maintain adequate sexual excitement, causing personal distress. Estimates of the FSAD market size put it on par with erectile dysfunction in males, and possibly larger.
Femprox exerts a relaxant effect on vulvar and clitoral blood vessels in women, leading to increased blood flow. This leads to pelvic engorgement and enhanced secretion activity of the vulvar epithelium. The resultant increase in lubrication and sensory feedback due to pelvic engorgement is believed to produce a clinically significant increase in sexual arousal in women with FSAD. It enables a rapid permeation of blood deep into the target tissues thus enabling a new pharmacotherapy for the treatment of FSAD through increasing the blood flow to tissue.
Apricus Bio is a revenue-generating pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes.