SkyePharma lifted by US approval
boost yesterday with the news that its new formulation of morphine
had been approved in the US.
The news follows on the heels of a $50 million (€42m) licensing deal the company signed earlier this week with US company First Horizon for an unnamed cardiovascular drug.
SkyePharma and US partner Endo Pharmaceuticals say that the Food and Drug Administration has approved DepoDur (formerly DepoMorphine), a sustained-release injectable formulation of morphine. The product is indicated for the treatment of pain following major surgery and could be available by the end of 2004, according to Endo.
This is a welcome piece of news for SkyePharma, which posted a 24 per cent drop in turnover to £53 million (€78m) last year, which it blamed on delays in signing a number of product licensing deals.
DepoDur is based on SkyePharma's proprietary DepoFoam technology, which consists of lipid-based particles containing water-filled chambers dispersed through the lipid matrix. The particles are 10-30 microns in diameter and are suspended in saline.
The resulting suspension resembles skimmed milk and can be injected through a fine needle. The water-filled chambers contain the active drug, and the lipid surrounding them is cleared by the body as the particles break down and deliver their drug payload. The technology can be adapted to provide delivery from between 1 and 30 days.
In this application, DepoDur is given as a single epidural injection before or during surgery and provides pain relief for up to 48 hours following surgery. Because there is no need for an in-dwelling catheter for continuous infusion, the product overcomes a major drawback to the otherwise theoretically desirable epidural route of administration for opioid analgesics. Such catheters can fall out or interfere with patient mobility and are a potential source of infections.
At the end of last year, SkyePharma submitted an application to the UK Medicines and Healthcare products Regulatory Agency for approval of DepoDur as a treatment for moderate-to-severe post-operative pain. The company said that, after clearance in the UK, it would seek registration in other European Union countries under the Mutual Recognition Procedure.
