Publication date: Jan 16, 2020
The FDA panel’s decision is “disappointing for patients suffering from chronic pain and the physicians that treat those patients who are currently relying on existing opioid therapies,” Nektar said in a Jan. 14 statement.
In briefing documents and a series of questions for the panel members, the FDA highlighted that the company had only conducted one pivotal efficacy study to support the drug’s review.
Because the company no longer needs to spend money on commercialization and post-approval studies for oxycodegol, Nektar said it expects cost savings of $75 million to $125 million this year.
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