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Citing the need to inspect a third-party contract packaging manufacturer, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)
The FDA has not raised any approvability concerns related to the efficacy, safety or
pharmacokinetics of ACER-001
NEWTON, Mass. and GENEVA, June 21, 2022 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (NASDAQ:ACER) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA ((SIX: RLF, OTCQB:RLFTF, RLFTY)) (Relief), announced today 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. The CRL states: “[The FDA’s] field investigator could not complete inspection of [Acer’s third-party contract packaging manufacturer], because the facility was not ready for inspection. Satisfactory inspection is required before [the NDA] may be approved. Please notify us in writing when this facility is ready for inspection.”
The FDA did not cite any other approvability issues in the CRL pertaining to the NDA, nor request any additional clinical or pharmacokinetic studies be conducted prior to FDA approval. The FDA did provide one comment in the CRL (identified as “not an approvability issue”) requesting additional existing nonclinical information to be provided in the resubmission of the NDA.
Acer 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.
“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,” said Chris Schelling, CEO and
