Apricus Biosciences Inc (NASDAQ:APRI), better known as a biopharmaceutical company developing innovative medicines in rheumatology and urology, reaffirmed its clinical and regulatory strategies. As per the reports, it would look forward to continuing same strategies to develop fispemifene as a response to the Complete Response Letter issued by FDA to Repros Therapeutics Inc.
Apricus has been working hard to develop fispemifene, which is a selective estrogen receptor modulator or SERM and can be used in the treatment of sexual dysfunction. It is quite common in men having symptomatic secondary hypogonadism.
The senior management of the company is looking forward to implementing these strategies and witnessing desired results. According to Barbara Troupin, Chief Medical Officer, Apricus, the company has closely worked with Food and Drug Administration to develop a perfect clinical strategy for fispemifene.
The ongoing Phase 2b study has covered all the points suggested by FDA to ensure that everything remain in line with no confusion towards the end of the study. As a result of the continuous hard work and devotion shown by the production and R&D team, Apricus is well-positioned to bring first of its kind SERM product in the United States.
Troupin further added that the company expects to report the final results of the Phase 2b study sometime in the first quarter of 2016. If everything falls in line the way it’s expected, Apricus will continue to work along with FDA towards planning the registration trials of fispemifene during the next year.
The Phase 2b clinical trial is a randomized, parallel arm and multi-center study in about 160 hypogonadal men aged between 18-64 with sexual dysfunction related to low levels of testosterone or secondary hypogonadism.
Apricus Biosciences Inc (NASDAQ:APRI) looks forward to conducting further trials to make this product marketable as soon as possible. Details of these trials will be announced in the near future.