The Swedish firms Orexo and Meda are celebrating a thumbs-up in the USA for their insomnia treatment Edluar.

The companies said that the US Food and Drug Administration has approved Edluar (formerly known as Sublinox) for the short-term treatment of insomnia characterised by difficulties with sleep initiation. The tablet is a fast-acting, sublingual formulation of zolpidem, the active ingredient found in the most-established hypnotic, Sanofi-Aventis’ Stilnox/Ambien.

Meda acquired the exclusive worldwide rights for Edluar from Orexo last year and expects to launch the product in the US market during the second half of 2009. The approval triggers a $5 million milestone payment to Orexo, which will also receive royalties.

Orexo chief executive Torbjorn Bjerke, noted that “this is the second product approved in a major market within 12 months and is an excellent achievement”. He added that the milestone payment and the anticipated product launch “will continue Orexo’s progress towards profitability.”

The other approval Mr Bjerke was referring to was for Abstral, a fast-dissolving under-the-tongue tablet of fentanyl partnered with the UK’s ProStrakan, for the management of breakthrough cancer pain in patients who are already receiving opioid analgesics. It has been launched in various European markets and a fortnight ago received marketing authorisation in France and `Spain.