Emerging generic pharmaceutical company, ANI Pharmaceuticals, Inc. is going to launch a new drug for the management of the symptoms and signs of both rheumatoid arthritis and osteoarthritis, as well as acute pain. Etodolac, which the company announced in a press release is going to begin to be commercialized, is a non steroidal anti-inflammatory drug that is prescribed for acute and long-term use.
ANI Pharmaceuticals plans to release Etodolac 300 mg oral capsules, which represents a $9 million market on a trailing 12-month basis in the United States alone, according to analysts IMS Health. The company will be the third to market the product in the country. ANI President and CEO Arthur S. Przybyl said they are “pleased to announce the launch of our second product from the portfolio of approved generic products we acquired from Teva in January 2014.”
The company, which has been dedicated to the commercialization of branded and generic narcotics, oncolytics, hormones and steroids, just last December 31, 2014 acquired previously marketed generic drug products from Teva Pharmaceuticals. The deal included a $12.5 million payment and a percentage of future gross profits, as well as 20 solid-oral immediate release products, 4 extended release products and 7 liquid products — all of them already approved by the U.S. Food and Drug Administration (FDA) as abbreviated new drug applications.
Etodolac was evaluated by ANI Pharmaceuticals in several clinical trials, according to its different indications, before being launched by the company. The effects of the drug in patients with osteoarthritis of the hip or knee was studied in double-blind, randomized, controlled clinical trials with 341 patients, in which 600 to 1000 mg per day of etodolac induced better results than placebo.
The clinical trials that included rheumatoid arthritis patients evaluated etodolac in combination with gold, d-penicillamine, chloroquine, corticosteroids, and methotrexate in 426 patients. The three-month study demonstrated the effectiveness of the drug in the management of the symptoms of rheumatoid arthritis, which is comparable to piroxicam 20 mg/day. In addition, the company completed a long-term study with 1,446 patients that treated 60% of patients for 6 months and 20% for three years of therapy, and in which 500 mg b.i.d. etodolac was as effective as 600 mg q.i.d. ibuprofen.
With these new offerings, ANI believes that they can effectively compete in the Rheumatoid and Osteoarthritis markets, and offer value-based choices to patients.