Location
Apricus Biosciences is headquartered in San Diego, California. The company, and its subsidiaries, has approximately 35 employees.
Products
Vitaros® is a rapid-onset (generally 5–15 minutes) topical cream for the treatment of erectile dysfunction. It contains Prostaglandin E1 as the active ingredient and the Company's proprietary permeation enhancer (NexACT®) which facilitates the delivery of the drug into the blood stream. The current formulation of Vitaros requires refrigeration and is delivered via a small individual dispenser. Vitaros has been approved for patient use in Canada and Europe and to date (January 24, 2015) has been launched by marketing partners in the United Kingdom (Takeda), Germany (Sandoz), Sweden (Sandoz) and Belgium (Sandoz). Six additional European territories are expected to launch Vitaros during 2015.
Apricus has developed a room temperature formulation of Vitaros which is housed and delivered in a small, custom developed, disposable dispenser or "room temperature device" (RTD). Initial production of Vitaros RTD has commenced in order to generate the required stability data required for marketing approval. The Company continues to expect its commercial partners to launch the Vitaros RTD in 2016.
In November 2007 Apricus Biosciences sold the rights for the refrigerated formulation of Vitaros in the US to Warner Chilcott.
Read the full text
Fispemifene is a new chemical entity initially being pursued for the treatment of low testosterone (secondary hypogonadism) in males. Apricus plans to begin a Phase 2b clinical trial with fispemifene in this indication in the first half of 2015, with top-line data expected to be reported by the end of 2015. Apricus in-licensed the U.S. rights to fispemifene from Forendo Pharma in Q4 2014. Since then, it has transferred the regulatory filings from Forendo, developed a Phase 2b clinical trial protocol, held a scientific advisory board meeting with experts in the field to refine its development strategy, initiated the manufacturing process for the drug, and begun the clinical trial site selection process.
RayVa™ is a topical cream for the treatment of Raynaud's phenomenon, a circulatory disorder affecting the hands and feet. Patient enrollment commenced in December 2014 for a 45-patient Phase 2a clinical trial for RayVa which is expected to be completed and results announced in the second quarter in 2015. RayVa has the potential to be the only FDA approved treatment for this debilitating condition. RayVA contains Prostaglandin E1 as the active ingredient and Apricus' permeation enhancer (NexACT) which facilitates the delivery of the drug into the blood stream.
Femprox® is a topical cream for the treatment of female sexual interest / arousal disorder. It contains Prostaglandin E1 as the active ingredient and a permeation enhancer (NexACT) which facilitates the delivery of the drug into the blood stream.
NexACT Technology
NexACT® is a proprietary water-soluble small molecule permeation enhancer which temporarily changes the permeation dynamics of the lipid bi-layer and transiently loosens the tight junctions between the cells so that active drug molecules can be rapidly absorbed into systemic circulation. The NexACT technology is used in both Vitaros and RayVA. It can also improve the solubility of compounds resulting in enhanced drug permeation.
