naloxone (OX124) / Orexo - LARVOL DELTA

Orexo announces FDA acceptance of New Drug Application filing for OX124, a high-dose rescue medication for opioid overdose (PRNewswire) - "Orexo AB...announces the New Drug Application (NDA) for OX124 has been accepted for review by the US Food and Drug Administration (FDA). OX124 is a nasal rescue medication for opioid overdose containing a high dose of naloxone and is the first product based on Orexo´s world-class drug delivery platform, amorphOX^®. The PDUFA date is set to July 15, 2024, but recent review processes in the category indicate a risk of some delay....OX124 is protected by patents until 2039."

NDA • Patent • PDUFA date • Addiction (Opioid and Alcohol) • CNS Disorders

"Orexo shares new timeline for the high-dose rescue medication for opioid overdose, OX124 https://t.co/YBqG8IRnzN" (@CisionNews)

Addiction (Opioid and Alcohol) • CNS Disorders

"Orexo uppdaterar tidplanen för högdosläkemedlet vid opioidöverdos, OX124 https://t.co/hhjOfxYkLH" (@CisionNews)

Orexo submits New Drug Application to FDA for OX124, a high-dose rescue medication for opioid overdose (PRNewswire) - "Orexo AB...today announces the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its lead pharmaceutical pipeline asset, OX124, a nasal rescue medication for opioid overdose. OX124, is based on Orexo´s drug delivery platform amorphOX® and contains a high-dose of naloxone. The submission is supported by data from the pivotal study in healthy volunteers...Orexo is planning to initiate the US launch during H1 2024."

Launch US • NDA • Addiction (Opioid and Alcohol)

"Orexo submits New Drug Application to FDA for OX124, a high-dose rescue medication for opioid overdose https://t.co/1b06Z3HrvK" (@CisionNews)

NDA • Addiction (Opioid and Alcohol) • CNS Disorders

"Orexo expects FDA filing of OX124 mid 2022 https://t.co/0Jjhrd2mA7" (@CisionNews)

"Orexo strengthens IP rights for overdose rescue drug OX124 https://t.co/p0wzjXhqiE" (@CisionNews)

"Orexo stärker patentskyddet för OX124 - akutläkemedlet vid överdos https://t.co/IX9WqiQ5xy" (@CisionNews)

Latest Prevention and Wellness News - "In the second study, researchers led by Kirk Evoy...studied the availability of naloxone at chain pharmacies in the state....According to Evoy, in drugstores that have drugs in stock and offer without a prescription, patients go to pharmacies without seeing a doctor, and about 70% of chain pharmacies contacted naloxone on the same day....'Hopefully, the study serves as a phrase that encourages local pharmacies to take action to better educate pharmacists and support staff regarding the company's policies regarding naloxone access laws and naloxone dispensing,' Evoy said."

Media quote

Regenerative Medicine: MSC Therapy (Practical Pain Management) - "Sustained analgesia by MSCs appeared to require activation of central brain stem µ-opioid receptors and CXCL1/CXCR2 chemokine signaling....In addition, intrathecal MSCs effectively reduced nerve injury-induced neuroinflammation in the spinal cord, reflected by microglia and astrocyte activation and increased expression of IL-1-beta, IL-6, and TNF....The potential to ameliorate symptoms and modulate disease processes with MSCs requires a conscientious and scientifically-driven approach to be fulfilled."

Online posting

Q4 Incl. full year report 2019 (PRNewswire) - "Q4 2019 highlights: Zubsolv® US net revenues of SEK 190.5 million (166.7), up 14.3 percent in SEK and 7.5 percent in local currency; Despite increased competition from generics in the first half of 2019, we have managed to grow Zubsolv® sales on a full year basis...We intend to complete the development program for OX124, a naloxone rescue medication for opioid overdose, during 2020, with the potential for FDA approval in 2021. The naloxone rescue market is currently valued at USD 300 million, with strong double-digit growth, and OX124 could be a more effective product on the market with a unique nasal delivery system."

Commercial • Regulatory • Sales

Domain-specific CD6 monoclonal antibodies identify CD6 isoforms generated by alternative-splicing. (PubMed, Immunology) - "Using engineered isoforms of CD6 including or excluding each of the three SRCR domains, either expressed at the membranes of cells or in soluble forms, we provide conclusive and definitive evidence that domain 2 of CD6, previously not identifiable, can be recognized by the CD6 mAbs OX125 and OX126, and that OX124 targets domain 3 and can block the interaction at the cell surface of CD6 with its major ligand CD166. Alternative splicing-dependent CD6 isoforms can now be confidently identified. We confirm that following T cell activation there is a partial replacement of full-length CD6 by the CD6Δd3 isoform, which lacks the CD166-binding domain, and found no evidence for the expression of other CD6 isoforms at the mRNA or protein levels."

Journal