The U.S. Food and Drug Administration (FDA) has approved celecoxib capsules — a generic form of Pfizer’s Celebrex — to treat inflammation and pain in juvenile idiopathic arthritis (JIA) and other chronic conditions.
India-based Unichem Laboratories was granted approval of its abbreviated new drug application (ANDA) for four doses of the celecoxib generic, the company announced in a press release.
With the FDA approval, the generic, given in capsules, will now be available at 50 mg, 100 mg, 200 mg, and 400 mg doses.
Celecoxib is a non-steroidal anti-inflammatory drug (NSAID), one of the most commonly prescribed medications for treating chronic conditions such as arthritis. NSAIDs, which include ibuprofen, also are available as over-the-counter medications such as Advil and Motrin, among other brands.
The medication mainly works by blocking cyclooxygenase 2 (COX-2), an enzyme that helps release prostaglandins — lipid (fat) molecules that can drive inflammation — after an infection or injury. By targeting COX-2, celecoxib can help ease inflammation and pain.
Other NSAIDs can inhibit both COX-2 and COX-1 at therapeutic doses. However, a selective COX-2 inhibitor such as celecoxib may cause fewer gastrointestinal adverse effects — the most common side effects of NSAIDS — than therapies that target both COX enzymes.
Celebrex has been approved by the FDA to treat JIA since 2006 and is only available via a prescription. In JIA, Celebrex has been approved to treat patients ages 2 or older.
The SINCERE Phase 4 trial (NCT00688545) assessed Celebrex’s long-term safety profile compared with nonselective NSAIDs in children with JIA, ages 2 to 17.
The results showed that the rate of adverse events was similar between both groups, at 52.9% in the Celebrex group and 52% in participants on non-selective NSAIDs.
Gastrointestinal disorders — including abdominal pain, nausea, diarrhea, and gastroesophageal reflux — were the most commonly reported adverse events related to treatment.
For an ANDA application, companies are often not required to provide data on animal or human studies to show that their medication is safe and effective. Yet, they must prove that the generic works in a similar way to the original therapy and demonstrate that the same amount of its active ingredients is delivered to the patients’ bloodstream in the same period of time.
In addition to JIA, the new generic is indicated for the treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute pain, and primary dysmenorrhea (pain caused by menstruation).
The product will be commercialized from Unichem’s Goa plant.