US-based Iroko Pharmaceuticals has announced the filing of a new drug application for Zorvolex, a nonsteroidal anti-inflammatory drug, with the Republic of Lebanon Ministry of Public Health (MOPH) for treating pain.
Algorithm signed a licensing agreement with Iroko Pharmaceuticals in 2013 and has filed the new drug application for Zorvolex (diclofenac) capsules in Lebanon.
Algorithm CEO Selim Ghorayeb said: "We are pleased with this first milestone to come from our partnership with Iroko and look forward to bringing this low dose NSAID option to patients and prescribers throughout the MENA region."
Under the licensing agreement terms, Algorithm gained exclusive rights to market and sell Zorvolex to countries in the Middle East and North Africa. Iroko Pharmaceuticals will continue to retain all marketing rights to Zorvolex in the US.
Iroko Pharmaceuticals said that it is in discussions with additional companies to bring Zorvolex to other international markets.
In October 2013, the US Food and Drug Administration (FDA) approved Zorvolex for treatment of mild to moderate acute pain in adults. Zorvolex has been available in US pharmacies since January 2014.
The FDA is currently reviewing a supplemental new drug application seeking approval of Zorvolex for the treatment of osteoarthritis pain. Zorvolex is not currently approved for marketing in any other country.
Iroko Pharmaceuticals president and CEO John Vavricka said: "The first Zorvolex filing outside of the US is a tremendous milestone for the company, building on a very busy first half of 2014, which included the Zorvolex US launch, FDA approval of its second low dose NSAID and receipt of critical patents for both products."
Zorvolex contains diclofenac as submicron particles and has been developed using SoluMatrix Fine Particle Technology that is now available by prescription.