Just three months after Titan Pharmaceuticals' ($TTNP) experimental treatment for opioid addiction was red-flagged at the FDA, Orexo has cruised to an approval for a rival therapy. The Swedish specialty pharma outfit has been given the green light to start marketing the sublingual Zubsolv, a combination of buprenorphine and naloxone for use in treating withdrawal symptoms from heroin and opioid pain killers.
Shares of Orexo shot up more than 12% on the news Thursday.
Orexo has high hopes for this treatment, estimating peak potential sales at $500 million. The company will now begin to compete with Reckitt Benckiser Group's Suboxone (also buprenorphine and naloxone) and Subutex. Reuters reports that those two drugs reaped $1.3 billion in sales last year. Curiously, both drugs lost patent protection about four years ago, but Reckitt switched over to a successful film version that could be dissolved under the tongue.
Titan Pharmaceuticals had set out to develop an implanted version of generic Suboxone that would provide relief from withdrawal symptoms for 6 months. But the FDA stiff-armed the company's application and the agency's expert panel--which had recommended an approval--demanding more efficacy and safety data before it would consider an approval.
"The approval of Zubsolv, which is based on our advanced formulation capabilities and developed using our proprietary technology, is a great tribute to the world class pharmaceutical formulation team at Orexo," said Orexo CEO Nikolaj Sørensen. "Today is a proud day for Orexo with the third product approved in the US coming out of our R&D department in Uppsala."
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