Market Overview

FDA Snubs Mallinckrodt's Abuse-Deterrent Opioid Reformulation

Share:
FDA Snubs Mallinckrodt's Abuse-Deterrent Opioid Reformulation
Related
28 Stocks Moving In Monday's Pre-Market Session
31 Stocks Moving In Wednesday's Pre-Market Session
Intellipharmaceutics up 20% on FDA nod for generic Pristiq (Seeking Alpha)

Mallinckrodt PLC (NYSE: 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.

Related Links:

The Daily Biotech Pulse: Legal Victory For Boston Scientific, Alder Gets New CFO, FDA Go-Ahead For BioXcel

The Week Ahead In Biotech: Conferences, Clinical Trials And Earnings

Posted-In: News Health Care FDA Top Stories Trading Ideas General Best of Benzinga

 

Related Articles (MNK)

View Comments and Join the Discussion!

Mid-Morning Market Update: Markets Open Higher; Vera Bradley Misses Q3 Estimates

Broken Record: After Rally Fizzled Tuesday, Another One Appears Possible On China