Acrux granted four US patents, licensee meets with FDA

Acrux (ASX:ACR) has been granted four more US patents relating to its transdermal drug delivery technology.

The four 'continuation in part' patents provide additional protection for systemic delivery of drugs in specific therapeutic areas, namely analgesics, hormones, anti-Parkinson's agents and anti-emetics.

"The patents do not provide new areas of intellectual property but make sure that specific areas that are strategically important to Acrux, where we're developing products, are further protected," said Acrux CEO and managing director Igor Gonda.

Acrux now has six patents granted in the US.

The new patents expire in February 2017. Acrux's transdermal drug delivery systems consist of a therapeutic drug, a dermal penetration enhancer (a safe skin-tolerant ester sunscreen) and a volatile liquid and the patents provide protection for a number of products in Acrux's pipeline.

FDA meeting

Vivus, Acrux's US-based licensee for its transdermal testosterone spray for women Testosterone MDTS, met with the US Food and Drug Administration (FDA) on September 12 to share results from its phase II study for the use of testosterone to treat hypoactive sexual desire disorder and to discuss phase III requirements.

While phase III protocols were not agreed upon, the FDA provided Vivus with guidance on size and duration requirements and Vivus will be completing the design of phase III safety and efficacy studies for Testosterone MDTS over the next few months.

"The FDA told us what they were interested in, and now we're responding to them with specific proposals for phase III duration and size," said Gonda.