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FDA Sets Review for Nasal Opioid Rescue Drug
The product, OX124, uses a powder-based technology that provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA review date is July 15, 2024.
The FDA has accepted the new drug application and assigned a Prescription Drug User Fee Act date (PDUFA) of July 15, 2024, for Orexo’s OX124. The product is a nasal rescue medication for opioid overdose containing a high dose of naloxone and is the first product based on Orexo´s drug delivery platform, amorphOX.
AmorphOX is a powder-based technology that provides rapid absorption and high bioavailability of naloxone.
Drug overdose continues to be a major public health issue in the United States. From 2020 to 2021, opioid deaths rose 15%, according to CDC. More than 75% of the drug overdose deaths in 2021 involved an opioid.
Nikolaj Sørensen
“OX124 has the potential to reduce the acceleration in fatal overdoses caused by the widespread misuse of synthetic opioids, Nikolaj Sørensen, president and CEO of Orexo said in a press release. “With approval, we intend to initiate commercial activities during the second half of 2024 with a focus on obtaining reimbursement ahead of a broader launch into retail pharmacies early in 2025.”
The submission is supported by data from a pivotal study in healthy volunteers, where OX124 showed a significantly faster and higher absorption of naloxone compared with intramuscular dosing with an injection reference product. In addition, development formulations of OX124 have in a previous exploratory clinical study in healthy volunteers demonstrated a more rapid absorption and higher bioavailability compared with the market leading naloxone rescue medication, even with the same dose as the comparator.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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