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Mar 16, 2009

Orexo Receives FDA Green Light for Insomnia Drug

  • FDA approved Edluar, an insomnia therapy from Orexo. Partner, Meda, will have to pay Orexo $5 million according to their agreement inked in April 2008.

    Edluar 5 mg and 10 mg sublingual tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Meda expects to launch the drug in the second half of this year.

    Meda gained worldwide rights to Edluar and a nasal spray for rhinitis with an up-front $90 million fee. The company also agreed to pay up to $30 million if Edluar was sanctioned. Labeling under the current approval triggered only $5 million. Sales-based success fees could total $60 million.



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Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

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