Naloxone OTC Switch Application On Horizon Thanks To $3.4M Funding From Purdue

Harm Reduction Therapeutics, which has sought funding for a US Rx-to-OTC new drug application, receives grant from Purdue Pharma that enables filing and launching the product in a targeted 100,000 retail locations within two years.

Harm Reduction Therapeutics Inc. estimates the first Rx-to-OTC switch for naloxone could hit the US market within 18 to 24 months, thanks to a $3.42m grant provided by opioid drug maker Purdue Pharma LP.

The low-cost nasal spray, an opioid antagonist indicated for complete or partial reversal of opioid overdose – including respiratory depression...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA

ACIP Upheaval Leaves Merck & Co. In A Lurch

 

Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.

US FDA Chief Counsel Position Awaits HHS General Counsel Confirmation

 
• By 

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.

HHS Secretary Favors Regenerative Medicine Over Traditional Pharma: Blessing And Curse?

 

Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.

Generic Drug Office’s Policy Staff Returning To US FDA

 

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

More from Agency Leadership

Nipah Vaccine With ‘Pandemic Potential’ Wins EMA PRIME Designation

 

The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.

Pink Sheet Podcast: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget Cuts

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.

EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.