The company, best known for its development of treatments for obesity and weight management, is broadening its portfolio following the proposed acquisition, announced earlier this month, of Cincinatti-based 40Js.
As part of its planned acquisition, M Pharma will continue to advance the development of a patented topical drug product for the treatment of female sexual dysfunction (FSD).
“Unlike the other two drugs approved by the US Food and Drug Administration [FDA] to treat FSD, our topical drug product would focus on women with orgasm and arousal difficulties,” said Gary Thompson, chief executive officer of M Pharmaceutical USA.
“Valeant’s Addyi, recently acquired from Sprout Pharmaceuticals, is indicated only for HSDD (desire disorder) with a number of FDA-imposed prescription and marketing restrictions,” Thompson noted.
“Intrarosa, by Endoceutics, is indicated for dyspareunia (pain with intercourse) with certain prescribing restrictions. Our proposed treatment is topical, local and non-systemic, with daily and on-demand use, while being non-hormonal and not a central nervous system drug,” he added.
Based on the core attributes of its treatment, the safety profiles of the active and inactive pharmaceutical ingredients, the dosage and delivery form, M Pharma expects the product will be extremely well tolerated and highly effective for a large number of women suffering from FSD.
If Thompson’s prediction is correct, then it should have a very good chance of being approved by the FDA.
Story by ProactiveInvestors