FDA approves Nouress for treating neonatal patients requiring total parenteral nutrition.- Avadel Pharma

Avadel Pharmaceuticals plc a company focused on developing FT 218, an investigational, once-nightly formulation of sodium oxybate for treating narcolepsy, announced that the FDA has approved Nouress (AV 001), a cysteine hydrochloride injection, a critical drug for treating neonatal patients requiring total parenteral nutrition .

In addition, Avadel announced that the United States Patent and Trademark Office (USPTO) recently issued United States Patent No. 10,493,051 covering cysteine solutions, including the approved Nouress product. This patent is listed in the Orange Book for Nouress and is set to expire in March of 2039. Avadel has additional U.S. patent applications pending for Nouress.

Comment: Nouress will compete with ELCYS , from Exela Pharma Sciences, a sulfur-containing amino acid indicated to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN. It can also be added to amino acid solutions to provide a more complete profile of amino acids for protein synthesis. ELCYS was FDA approved on 31 May 2019.