FDA unanimously shuts down Nektar’s opioid painkiller
According to reporting by Reuters, the unanimous decision against the drug resulted from concerns over the potential for abuse of the opioid painkiller, oxycodegol. As well as this, Nektar Therapeutic chose to submit data to US Food and Drug Administration (FDA) based on only one pivot efficacy study rather than two studies.
After the rejection, Nektar released a statement outlining its ‘disappointment’ in the decision and that it would withdraw its new drug application (NDA), ending its investment in the development program.
With funding cut from the drug candidate, the company noted that it would look to make cost savings of between $75m (€67.2m) and $125m (€112m) in 2020, based on the estimated expense of commercialization and post-approval studies.
The share price of Nektar has dropped 16% since the advisory committee’s recommendation was made, despite the positive news the company announcement last week on its extended collaboration agreement with Bristol-Myers Squibb.
The decision on oxycodegol comes as the FDA moots various measures to limit the risk of harm posed by opioid painkillers, amid the ongoing opioid epidemic in North America that has resulted in a number of lawsuits targeting manufacturers.
