Purdue Pharma vow not to profit from fast tracked opioid overdose antidote

pharmafile | March 18, 2019 | News story | Sales and Marketing FDA, OxyContin, Purdue Pharma, nalmefene hydrochloride, opioids 

The FDA has granted OxyContin drugmaker Purdue Pharma, fast track designation for opioid overdose antidote nalmefene hydrochloride (HCl) injection. However, the besieged firm has vowed not to profit from sales of the drug.

The pledge comes after evidence presented in court showed Purdue executives had discussed their hopes of entering the lucrative and ‘attractive’ market for addiction treatments as early as 2014.

The Connecticut-based firm were in recent news said to be exploring bankruptcy as a means of dodging thousands of lawsuits related to the company’s alleged role in fuelling the opioid crisis.

US firm Baxter’s version of the drug was previously approved as an antidote for opioid overdoses in 1995. Sold under the brand name Revex, the drug was discontinued in 2008, due in part to poor sales. As such, Purdue’s version is not likely to be a major money maker for the firm.

As noted in a HHS statement from 2018: “Injection nalmefene is approved by the FDA for opioid overdoses, but the drug was removed from the U.S. market in 2008 due to low sales and is no longer available.  Returning nalmefene to market in an easy-to-administer intranasal formulation may be an important addition to the nation’s preparedness for current and emerging opioid threats.”

“Fentanyl and illicit opioid deaths continue to increase in the United States, fuelled increasingly by overdoses of this class of compounds. We urgently need new and potentially more effective treatments to combat opioid overdose than are available today,” said Dr Craig Landau, president and CEO, Purdue Pharma.

“The Fast Track designation from the FDA for nalmefene HCl underscores the importance and time sensitivity of this unmet medical need. We will continue our efforts to make nalmefene HCl injection available as quickly as possible, as it has the potential to be an important option to help address this public health emergency.”

Louis Goss

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