Pharmaceutical major Dr Reddy’s Laboratories has received approval from the US Food and Drug Administration (USFDA) for Elyxyb (celecoxib oral solution).
Elyxyb, previously known as DFN-15, is indicated for the acute treatment of migraine with or without aura in adults.
It is is the latest product emerging from Hyderabad-based Dr Reddy’s portfolio of ‘successful’ acute migraine treatments. The company is working to commercialise the product through partners.
“We are excited about the approval of Elyxyb. It reaffirms our commitment to innovation and develop meaningfully differentiated products that address significant unmet needs of patients and physicians, leading to better health outcomes,’’ said Erez Israeli, CEO, Dr Reddy’s Laboratories, in a release on Wednesday.
Anil Namboodiripad, Senior Vice-resident, Proprietary Products, Dr Reddy’s, said: “Elyxyb is an oral solution of celecoxib formulated using a self-micro emulsifying drug delivery system that improves solubility and bio-availability of the drug, leading to better absorption.
“The results from pivotal studies with Elyxyb established efficacy of celecoxib in the treatment of migraine with very few adverse events.’’