Drug development companies have developed innovative approaches to drug formulation to avoid or reduce the adverse events that accompany pain management drugs. Iroko Pharmaceuticals has been building a portfolio of low dose Non Steroidal Anti Inflammatory Drugs. It presented data from a Phase 3 trial of its osteoarthritis drug SoluMatrix Meloxicam at the Annual European Congress of Rheumatology in Paris this week.
The 12 week Phase 3 multi-center, double-blind and placebo-controlled study included 403 patients with osteoarthritis in their knee or hip. The drug uses 30 percent less Meloxicam than what’s currently available on the market. Significantly more patients reported their condition as improved compared with the placebo group, according to a company statement.
The company’s SoluMatrix Fine Particle technology reduces the size of the drug’s particles. The greater surface area means it can reach its maximum level in the blood faster than rival medications. For example, SoluMatrix Meloxicam is designed to act in half the time of other dosages on the market. 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 such as myocardial infarction, stroke, gastrointestinal ulcers, and gastrointestinal bleeding that can accompany NSAIDs when they are taken over any significant amount of time.
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Osteoarthritis is one of the most common causes of disability. It affects 27 million adults, according to the Centers for Disease Control.
In a phone interview with Iroko CEO John Vavricka, he pointed out that the lower dosages are especially useful for a patient population that have to take NSAIDs over a long period of time. “We look at ourselves as providing more options. The people with osteoarthritis are on medication for a really long time. They really need to take something for their pain or they have difficulty moving around. If you can reduce the dosage over someone’s lifespan that can make a big difference.”
He added that it expects to file an NDA for SoluMatrix Meloxicam by January 2015.
The company has received FDA approval for two other drugs. In February it got the greenlight for its indomethacin capsules, Tivorbex, in 20-mg and 40-mg doses to treat mild to moderate acute pain in adults. Last year it secured approval for Zorvolex.
