Dublin-based Avadel Pharma announced that the U.S. Food and Drug Administration had approved its Nouress for neonatal patients requiring total parenteral nutrition.
Dublin-based Avadel Pharma announced that the U.S. Food and Drug Administration (FDA) had approved its Nouress for neonatal patients requiring total parenteral nutrition (TPN).
Nouress (AV001) is a cysteine hydrochloride injection. TNP is a way of feeding that bypasses the gastrointestinal tract. A special formula is typically provided via a vein that supplies most of the neonate’s nutritional needs. This is performed when the babies can’t or shouldn’t be fed food or fluids by mouth.
“We are pleased to receive FDA approval for Nouress, which validates our strategy of developing innovative medicines for patients,” said Greg Divis, Avadel’s chief executive officer. “Nouress is the fourth FDA approved product in our sterile injectable hospital business.”
The company is working on how to best commercialize the product in the U.S. Despite the approval, the company’s shares were down about 17% at the news. The reason for that is likely related to a competitor, Exela Pharma Sciences’ Elcys, which was approved by the FDA in April.
Avadel also points out that there hasn’t been a reliable supply of cysteine hydrochloride injection previously, so U.S. markets imported it from Canada under special FDA rules. Now that Nouress and Exela’s Elcys have been approved, Avadel believes the U.S. market needs will be met, which should result in the FDA halting import or U.S. marketing of unapproved cysteine hydrochloride injection products.
Exela announced on May 31 that they planned an immediate launch of Elcys, emphasizing that its New Drug Application (NDA) was not an abbreviated NDA (ANDA), but the result of “significant research and development aimed at lowering the aluminum content in the drug product.”
Elcys is indicated for use as an additive to amino acid solutions for TPN and in adults and pediatric patients with severe liver disease who have impaired enzymatic process and require TPN. It can also be added to amino acid solutions to provide a more complex protein synthesis profile.
Avadel suggested the company’s focus was more on using revenue generated by Nouress to advance another program.
“The cash flow generated by this legacy business is supporting the clinical development costs from our lead program, FT218, which is currently expected to announce topline data from the pivotal Phase III REST-ON trial in the second quarter of 2020,” Divis said. “We believe that as a once-nightly formulated sodium oxybate, FT218, if approved by the FDA, has the potential to take a significant share of the twice-nightly sodium oxyate market, which is currently valued at an estimated annualized rate of $1.7 billion.”
The U.S. market for cysteine hydrochloride appears to be around $50 million, a significantly smaller market.
In addition to announcing the approval of Nouress, Avadel announced the U.S. Patent and Trademark Office (USPTO) had recently issued a patent covering cysteine solutions, including Nouress. That patent will run until March 2039. The company also has more U.S. patent applications pending for Nouress. Elcys was also recently granted a U.S. patent, which is part of Avadel’s assessment of the market for Nouress.
