The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to Acer Therapeutics’ ACER New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension in the treatment of patients with urea cycle disorders (UCDs).
The regulatory agency indicated in the CRL that its field investigator could not complete inspection of Acer’s third-party contract packaging manufacturer, because the facility was not ready for inspection.
However, FDA did not cite any other approvability issues in the CRL pertaining to the New Drug Application (NDA).
The company is collaborating with its third-party contract packaging manufacturer and cooperating with the FDA to address the issues indicated in the CRL.
Chris Schelling, CEO and Founder, commented : “While the outcome of the NDA review was not what we had hoped for, multiple rounds of labeling negotiations have already been conducted to date and we believe the recommendations raised by FDA can be appropriately addressed. We should be able to resubmit the NDA relatively quickly.”
Acer is planning to resubmit the updated NDA for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with UCDs in early-to-mid Q3 2022.
Shares of Acer Therapeutics are trading down 13 percent at $1.53 in the regular market session.