Dr Reddy gets USFDA nod for oral solution of migraine
Dr Reddy’s Laboratories Limited announced that USFDA has given an approval to ELYXYB (celecoxib oral solution 25 mg/ml). The company is working to commercialise this product through partners.
Earlier known as DFN-15, ELYXYB is used for the acute treatment of migraine with or without aura in adults. It is the latest product, which has formed a part of Dr Reddy’s portfolio that deals in treating acute migraine.
The company’s management further provided the information that ELYXYB is an oral solution of celecoxib formulation, using a self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption. This allows for administration of a lower dose without affecting its bioavailability.
In pivotal studies, ELYXYB demonstrated a rapid onset of action, which is critically important for patients suffering from acute migraine attacks. Its results established efficacy of celecoxib in the treatment of migraine with very few adverse events. ELYXYB’s oral solution dosage form makes it convenient for the patients to take immediately upon emergence of migraine attacks.
On Thursday, in the early morning session, the stock of Dr Reddy’s surged 2.1 per cent to Rs 3,936.35 from its previous close of Rs 3,856.75 on BSE.