Mallinckrodt PLC MNK announced the receipt of a complete response letter, or CRL, from the FDA on Wednesday.
What Happened
Mallinckrodt's generic subsidiary SpecGx LLC said it received a CRL from the FDA pertaining to its NDA for its investigational abuse-deterrent, immediate-release reformulation of its oxycodone hydrochloride tablets.
The pipeline candidate is being evaluated to manage pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
In the CRL, the FDA outlined areas that require further evaluation in order for a resubmission.
Why It's Important
A CRL is issued to an applicant if the FDA determines that the application or abbreviated application cannot be approved in its current form.
The FDA rejection comes after a joint setting of two FDA committees OK'ed the drug.
A joint committee of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee that met Nov. 14 to discuss the NDA voted 10-7 in favor of approving the drug.
Separately, the committees voted 12-5 for labeling the product as an abuse-deterrent product only by the nasal route of abuse.
What's Next
The company said it will continue to pursue a pathway to gain approval for the drug.
"We are evaluating the FDA's letter and will request a meeting in the coming weeks to discuss it further," Specialty Generics President Matt Harbaugh said in a statement.
Mallinckrodt shares were up 0.33 percent at $21.01 at the time of publication Wednesday. The stock had dropped more than 10 percent in pre-market trading.
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