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Nektar Slumps As FDA Panel Gives Thumbs Down To Opioid Pain Drug; Program Shelved

Nektar Slumps As FDA Panel Gives Thumbs Down To Opioid Pain Drug; Program Shelved

Shares of midcap biopharma Nektar Therapeutics (NASDAQ: NKTR) are retreating sharply following a negative verdict handed down by FDA staffers for its opioid pain drug.

FDA Panel Flashes The Red Signal

San Francisco-based Nektar said a joint sitting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, which discussed the NDA for its oxycodegol, earlier codenamed NKTR-181, did not recommend approval.

The company expressed disappointment at the disapproval of the Adcom committees, having created oxycodegol specifically to help the patients as well as physicians address the opioid abuse epidemic.

Nektar said it used well-established efficacy, safety and human abuse potential study designs that had been used for many prior FDA approvals of opioid medications.

Oxycodegol absorption through the central nervous system happens at a much slower rate than opioid drugs that possess abuse potential, the company claimed.

The review period turned out to be a long-drawn process for Nektar, as the company said in July the FDA postponed an originally Adcom meeting as part of a broader delay for all opioid analgesics amid the regulatory body's exploration of a number of scientific and policy issued related to this class of drugs.

Program Discontinued

As a fallout of the adverse panel vote, Nektar has decided to withdraw the NDA and not to make any further investment into the program.

The folding up of the oxycodegol program, according to the company, is expected to save between $75 million and $125 million in 2020.

Incidentally, IntelliPharmaCeutics International Inc.'s (OTC: IPCIF) NDA for an extended-release oral tablet formulation of oxycodone will be reviewed by the same committees Wednesday.

Nektar's was sliding 12.91% to $24.35 per share.


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