Apricus Bioscience Inc (Public, NASDAQ:APRI)

[Michael Scally MD]

Apricus Bioscience Inc (Public, NASDAQ:APRI) APRI, Drug Delivery System & Technology, Patient Friendly Drugs San Diego by Apricus Bio
IR: Apricus Bio APRI NexACT, Patient Friendly Drugs San Diego by Apricus Bio

GF: Apricus Bioscience Inc: NASDAQ:APRI quotes & news - Google Finance
YF: APRI: Summary for Apricus Biosciences Inc.- Yahoo! Finance
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Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.


Vitaros® (topical alprostadil and DDAIP for the treatment of Erectile Dysfunction: approved in Canada, previously filed in US, and to be filed in Europe and MENA 2011 Q2)

Vitaros® offers rapid onset with significant efficacy, tolerability and a favorable safety profile, including patients with compromised cardiovascular system such as diabetics or patients not responding to Viagra after a prostatectomy.

Phosphodiesterase inhibitors are effective in Erectile Dysfunction but can cause serious cardiovascular safety issues as well as significant side effects such as headache, muscle ache and impaired hearing and vision. Availability of a safer and effective treatment would address an unmet medical need. Apricus Bio's alprostadil topical cream Vitaros® in combination with the NexACT® proprietary permeation enhancer (DDAIP.HCL) has been designed to provide a rapid onset with significant efficacy, tolerability and a favorable safety profile.

Vitaros® has been studied in over 3,300 patients including difficult to treat populations (diabetes, cardiac issues, sildenafil failures, prostatectomies, patients on nitrates and alpha blockers.) Vitaros® demonstrates clinical efficacy and an excellent safety profile versus currently approved oral medication. Vitaros® is approved in Canada .The NDA was filed in the U.S. Marketing authorization for Vitaros® is scheduled to be filed in Europe, and certain Gulf and Middle Eastern countries during the 2011. Apricus Bio is seeking ex-US partners, excluding Asia, Australia and New Zealand.


See: https://thinksteroids.com/community/threads/134310140

 

[Michael Scally MD]

[Money Down the Drain] Apricus Biosciences Announces $10 Million Registered Direct Offering Press Releases | Investors | Apricus Biosciences

 

[Michael Scally MD]

Apricus Reports [Failed] Top-Line Phase 2b Data for [SERM] Fispemifene in Symptomatic Secondary Hypogonadism
Press Releases | Investors | Apricus Biosciences

Fispemifene Failed to Achieve Statistical Significance in Key Clinical Benefit Endpoints Despite Increase in Testosterone Levels.

Apricus Biosciences, Inc. (Nasdaq:APRI) announced top-line results from the Phase 2b proof-of-concept study of fispemifene in men with secondary hypogonadism and sexual dysfunction.

This study was a randomized, double-blind, placebo-controlled study enrolling approximately 160 men to assess safety and tolerability, as well as the ability of fispemifene to improve the sexual function outcomes of erectile function and low libido compared to placebo in men with secondary hypogonadism.

While fispemifene at 450mg demonstrated statistically significant improvements in total, percent free and percent bioavailable testosterone compared to placebo (P < 0.0001 at both 4 and 8 weeks), the magnitude of the increase was not sufficient to achieve statistical significance for either the erectile function primary endpoint or low libido secondary endpoint.

Erectile function was assessed using the International Index of Erectile Function erectile function domain (IIEF-EF) questionnaire and Sexual Encounter Profile (SEP) diaries and low libido/desire was assessed using the Psychosexual Daily Questionnaire (PDQ).

 

[Michael Scally MD]

Apricus Reports [Failed] Top-Line Phase 2b Data for [SERM] Fispemifene in Symptomatic Secondary Hypogonadism
Press Releases | Investors | Apricus Biosciences

Fispemifene Failed to Achieve Statistical Significance in Key Clinical Benefit Endpoints Despite Increase in Testosterone Levels.

Apricus Biosciences, Inc. (Nasdaq:APRI) announced top-line results from the Phase 2b proof-of-concept study of fispemifene in men with secondary hypogonadism and sexual dysfunction.

This study was a randomized, double-blind, placebo-controlled study enrolling approximately 160 men to assess safety and tolerability, as well as the ability of fispemifene to improve the sexual function outcomes of erectile function and low libido compared to placebo in men with secondary hypogonadism.

While fispemifene at 450mg demonstrated statistically significant improvements in total, percent free and percent bioavailable testosterone compared to placebo (P < 0.0001 at both 4 and 8 weeks), the magnitude of the increase was not sufficient to achieve statistical significance for either the erectile function primary endpoint or low libido secondary endpoint.

Erectile function was assessed using the International Index of Erectile Function erectile function domain (IIEF-EF) questionnaire and Sexual Encounter Profile (SEP) diaries and low libido/desire was assessed using the Psychosexual Daily Questionnaire (PDQ).

“While we did see statistically meaningful changes in testosterone levels into the low normal ranges with fispemifene, the compound’s ability to increase those levels sufficiently to demonstrate clinical benefit is limited, and may be an issue with the entire SERM class. The regulatory benchmark for approval of a compound in secondary hypogonadism in men is the achievement of a symptomatic clinical benefit, using patient-reported outcome (PRO) measures in a defined patient population. Achievement of biochemical or PK normalization of testosterone into the low normal range is not sufficient for regulatory purposes,” said Barbara Troupin, MD, Chief Medical Officer of Apricus.