Acer Therapeutics, Relief Therapeutics Receive CRL From FDA For ACER-001 For UCDs

Pharmaceutical company Acer Therapeutics Inc. (ACER) and its collaboration partner, Relief Therapeutics Holding SA (RLFTF, RLFTY), announced Tuesday that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs).

The CRL indicates that the FDA cannot approve the NDA in its current form. Though it has not cited any approvability issues, the CRL states that FDA's field investigator could not complete inspection of Acer's third-party contract packaging manufacturer, because the facility was not ready for inspection. It added that satisfactory inspection is required before the NDA may be approved.

Acer said it is actively collaborating with its third-party contract packaging manufacturer and cooperating with the FDA to address the FDA's comments as soon as reasonably possible and currently intends 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.

The NDA for ACER-001 for UCDs was accepted for review by FDA on October 5, 2021 at which time FDA assigned a PDUFA target action date of Sunday, June 5, 2022.

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