The U.S. Food and Drug Administration has approved Iroko Pharmaceuticals’ drug Zorvolex to treat mild to moderate acute pain in adults, according to a company statement. It’s a milestone for the Philadelphia drug developer. which has been working on a new formulation to conform with the FDA’s Non Steroidal Anti Inflammatory Drug requirements issued in 2005.
Iroko Pharmaceuticals CEO John Vavricka said: “This marks a major achievement towards our goal of applying new technology to existing NSAIDs in order to address unmet medical needs in analgesia.”
Zorvolex is the first of the company’s drugs to use the new formulation to secure approval. The SoluMatrix Fine Particle technology reduces the size of the drug’s particles to a fine powder. The formulation was developed in response to the FDA’s public health advisory in 2005. It recommended that NSAIDs be used at the lowest effective dose for the shortest duration of time. The idea is to reduce the risk of serious cardiovascular and gastrointestinal problems that can accompany NSAIDs at higher dosages.
Reducing the drug particle size improves drug dissolution. The hope for this formulation is to reduce dosages and, at some point, give patients an option to take a drug with or without food, which has the potential to enhance adherence.