India-based pharmaceutical company Dr. Reddy’s Laboratories has received the US Food and Drug Administration (FDA) approval for ELYXYB (celecoxib oral solution 25 mg/mL) to treat acute migraine with or without aura in adults.

The company said that ELYXYB is the latest product from its portfolio of acute migraine treatments, and is working with the industry partners to commercialise the drug.

Dr. Reddy’s Laboratories proprietary products group senior vice president Anil Namboodiripad said: “ELYXYB is an oral solution of celecoxib formulated using a self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption1. This allows for administration of a lower dose without affecting bioavailability.

“In pivotal studies, ELYXYB demonstrated a rapid onset of action which is critically important to patients suffering from acute migraine attacks. The results from pivotal studies with ELYXYB established efficacy of celecoxib in the treatment of migraine with very few adverse events. For patients who suffer from the debilitating and disruptive effects of migraine, there continues to be a need for reliable and efficacious treatment options.”

ELYXYB can induce adverse cardiovascular thrombotic events and gastrointestinal events

The use of ELYXYB is limited and is not indicated for the preventive treatment of migraine.

The drug is not advised for patients with severe heart failure, history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs, known hypersensitivity to celecoxib, any components of the drug product, or sulfonamides, and in the setting of CABG surgery.

Use of ELYXYB can cause cardiovascular thrombotic events, including myocardial infarction and stroke, along with serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine.

Dr. Reddy’s Laboratories is engaged in providing a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.

The company operates through its three businesses divisions, pharmaceutical services and active ingredients, global generics and proprietary products.

Dr. Reddy’s Laboratories CEO Erez Israeli said: “We are excited about the approval of ELYXYB. It reaffirms our commitment to innovation and to develop meaningfully differentiated products that address significant unmet needs of patients and physicians, leading to better health outcomes.”