Imprimis to begin osteoarthritis cream PhIII, snags transdermal wound treatment

Imprimis' Impracor topical cream targets pain in patients with osteoarthritis.--Courtesy of Imprimis

Imprimis Pharmaceuticals ($IMMY) took two major steps this week, gaining approval to begin Phase III trials for its lead osteoarthritis topical cream candidate and getting hold of a novel transdermal treatment for wound management.

The San Diego-based company expects to bring Impracor, which delivers the non-steroidal anti-inflammatory ketoprofen via topical application with the drug delivery tech Accudel, into Phase III trials during the third quarter of this year. This week's institutional review board (IRB) approval allows the company to move forward with the placebo-controlled trial of acute pain treatment in patients with osteoarthritis of the knee.

The delivery tech, Accudel, as described by the company, "contains penetration enhancers which function synergistically to provide for rapid but controllable transport of an active medication from the Accudel cream into the skin and into the underlying soft tissue."

Imprimis will work with CROs Agility Clinical and Lotus Clinical Research to conduct the trial.

In other delivery tech news, Imprimis acquired for an undisclosed sum the transdermal wound management formulation IPI-120, a treatment invented by the Ohio-based Buderer Drug Company that could help reduce or stop bleeding while preventing or treating infection.

Tranexamic acid, approved in both intravenous and oral forms to stem blood loss during high-risk surgeries, may offer an orphan drug opportunity for Imprimis, especially with regard to its treatment potential for diseases such as hemophilia. Imprimis got its hands on the drug via a company asset purchase agreement with Buderer.

"Control of bleeding and infection is an integral part of the wound-healing process," said Imprimis Chief Medical Officer Joachim Schupp in a statement. "The transdermal, local intra-wound application or intra-cavity instillation of a novel pharmaceutical composition such as IPI-120 could become a valuable treatment option for conditions with high risk of bleeding and infections with a potential lower risk of systemic side effects."

The company notes that the U.S. wound care market is expected to reach nearly $21 billion by 2015, up from $16.8 billion in 2012.

- here's the Impracor release
- and here's the IPI-120 release

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