FDA Accepts Investigational New Drug Application for Alphaeon's Neurotoxin Evosyal

The FDA accepted the Investigational New Drug (IND) Application to conduct clinical studies for EVOSYAL, an botulinum toxin Type A neurotoxin that was acquired by Alphaeon last year as part of the acquisition of Evolus Inc.

“The product development team is very pleased that the research presented in the IND application was accepted by the FDA without questions, permitting the initiation of the clinical study to support safety and efficacy of this excellent product,” said Del Stagg, PhD, Alphaeon VP of Regulatory.

“Evosyal represents the state-of-the-art in both consistent manufacturability and potency as a 900 kDa neurotoxin molecular complex with high purity, both of which we believe will aid in achieving precise, predictable and long-lasting patient outcomes,” said John Gross, MD, Chief Scientific Officer for Evolus.

“FDA acceptance of our IND and clinical program is a critical milestone towards FDA approval and a testament to the strength of Alphaeon's clinical development team,” said Alphaeon Beauty President, J. Christopher Marmo PhD. “This approval is a key step in bringing U.S. consumers new best-in-class aesthetic products.”

According to the ASPS, botulinum toxin Type A was injected for cosmetic purposes more than 6 million times last year, accounting for over 2 billion dollars of consumer spend annually, which was a 3 percent increase from the previous year.

Alphaeon says it expects the initial clinical trial to be fully enrolled by the end of 2014.