Hyanalgese-D Filed For Approval In USA

Hyal Pharmaceuticals has submitted an application to the US Food and Drug Administration for Hyanalgese-D (diclofenac), a topical product intended for the rapid relief of pain associated with osteoarthritis.

If approved, Hyanalgese-D would be the first topical prescription product of its type to be approved for osteoarthritis. The application for approval follows extensive Phase III testing in over 600 patients in five countries. The product is based on the company's proprietary topical drug delivery system, Hyaluronan Induced Targeting (HIT) Technology. The company says that because the product is applied topically it has none of the gastrointestinal side effects associated with the oral versions of diclofenac.

In addition to the filing in the USA, at the end of last year Hyal filed for approval for the product in Canada, the UK and Ireland. The firm reported that on a worldwide basis it expects the market size to reach 60-80 million patients.