US regulators have approved Cipher Pharmaceuticals’ extended-release tramadol treatment for moderate to moderately severe chronic pain in adults.
The Candian-based firm have earmarked the first quarter of next year to launch tramadol into the US market after the approval of the US Food and Drug Administration.
Officials said an exact date for the entry is dependent on a patent dispute between Purdue Pharma and rival Par Pharmaceutical. A US court ruled in favour of Cipher in a similar case earlier this year.
Cipher president and chief executive Larry Andrews indicated the firm was close to agreeing a traditional milestone and royalty payment distribution agreement with a US company.
Mr Andrews added: “We could potentially launch at any time, once we get a partner on board. However, to be prudent, I think a potential license partner would like to know the outcome of the Par appeal before they go ahead and launch the product.” An appeal decision is expected in the fourth quarter.
Copyright Press Association 2010