SAN DIEGO, April 13, 2011 (GLOBE NEWSWIRE) — Apricus Biosciences, Inc. (“Apricus Bio”) (Nasdaq:APRI) announced today its filing with the U.S. Food & Drug Administration (“FDA”) requesting orphan drug designation for RayVa™, the Company’s drug candidate indicated for the treatment of Raynaud’s phenomenon in patients with systemic sclerosis.
Raynaud’s phenomenon is a condition in which the blood supply to fingers or toes is suddenly reduced. With less blood, the skin turns pale or white, and the fingers or toes become cold and numb.
The condition occurs in 4-15% of Americans, and is seven times more common in women than men. In many cases, Raynaud’s phenomenon is caused by cold or emotional distress, and is mostly an inconvenience. However, it also can be caused by other diseases, such as systemic sclerosis, an autoimmune disorder. Patients who develop Raynaud’s phenomenon as a consequence of systemic sclerosis can have severe complications. For example, the skin, subcutaneous tissues and muscles of the fingers and toes may weaken and shrivel, and in some cases, the fingers can develop ulcers. In extreme cases, the ulcers lead to gangrene, resulting in the loss of fingertips.
RayVa™ is designed to treat the condition by increasing the blood flow to the fingers and toes. One component of RayVa™ is the already approved drug, alprostadil, which has been clinically proven to boost blood flow. To create RayVa™, alprostadil is combined with Apricus Bio’s clinically-validated, proprietary NexACT® technology-a substance that temporary loosens the space between cells, allowing drugs to penetrate the skin. RayVa™ is designed to be applied as a cream to fingers or toes, delivering alprostadil directly to the area of need, in order to stimulate blood flow. Vitaros™, which also combines alprostadil with the NexACT® technology, has already been approved in Canada to treat erectile dysfunction.
“At Apricus Bio, we are continually expanding the potential uses for NexACT® and other active drugs such as alprostadil, while also attempting to bring new treatments to patients with unmet medical needs,” noted Bassam Damaj, Ph.D., Chairman, President and Chief Executive Officer of Apricus Bio. “Our orphan drug filing for RayVa™ is the second such orphan drug filing we have made in the last several years and represents another milestone for the Company.” In August 2008, the FDA granted orphan drug status for Apricus Bio’s proprietary drug PrevOnco™ for the treatment of liver cancer.
The FDA’s Orphan Drug Designation Program is designed to spur the development of drugs to treat rare medical diseases. A company whose product is granted orphan drug status receives, among other benefits, seven years exclusive commercialization rights for the treatment of the disease and an expedited review process.