Meda and Valeant Pharmaceuticals : Sublinox approved in Canada

July 25 2011 – The insomnia drug Sublinox (Edluar) has been approved in Canada. Meda and its partner Valeant expect to begin the launch in the fourth quarter 2011.


Sublinox will be marketed by the joint venture between Meda and Valeant, Meda Valeant Pharma Canada Inc. Meda has global rights to the drug and markets it in the USA since 2009 under the name Edluar. Orexo, who has developed the drug, is entitled to royalties on sales.


The approval is for short-term treatment of insomnia. Sublinox is based on Orexo's sublingual tablet technology. The drug is placed under the tongue where it rapidly disintegrates and the active substance zolpidem is absorbed through the oral mucosa... Orexo's Press Release - Meda's Press Release - Valeant's Press Release -

Orexo and Meda AB : The FDA has accepted for filing the registration application for Sublinox

July 29, 2008 - The submitted registration application for Sublinox^TM (OX22) has been accepted by the FDA as complete for substantive review after initial evaluation. Sublinox^TM contains the well-known active substance zolpidem and is based on Orexo´s sublingual technology, involving a rapidly disintegrating tablet placed under the tongue.



Meda AB acquired the exclusive world-wide commercialization rights for Sublinox^TM on April 14, 2008...
... The data supporting the product includes a clinical study in insomnia patients that was completed in October 2007... Orexo´s Press Release - [PDF] Meda AB's Press Release -

Meda : exclusive world-wide commercialization rights from Orexo of two patented drugs in late development phase; Sublinox and OX-NLA.

April 14, 2008 - Meda (STO:MEDAA) has acquired exclusive world-wide commercialisation rights from Orexo of two patented drugs in late development phase; Sublinox and OX-NLA.

Sublinox (treatment of insomnia) contains the well-documented active substance zolpidem, one of the world’s most used substances for this disorder. Sublinox uses a unique and patented sublingual tablet formulation for fast and effective absorption. A recent phase III study confirmed that Sublinox gave faster onset of action than other zolpidem tablet formulations.

Regulatory submission to the Food and Drug Administration (FDA) in the United States is expected before the 3rd quarter 2008... [PDF] Meda's Press Release - Orexo's Press Release -