Orexa BV

Orexo announced Tuesday that the FDA has issued a complete response letter (CRL) for OX124, the company's high-dose naloxone nasal spray developed for opioid overdose reversal.The CRL, received in response to Orexo's filing submitted last September, highlights two main issues. The agency wants Orexo to conduct another "human factors" (HF) study, a request that aligns with earlier discussions. However, it is also asking to see more technical data on the final commercial product, something Orexa said was "unexpected." The agency has not indicated a need for additional clinical or non-clinical studies.Orexa had been aiming for a potential launch later this year or early 2025. Since receiving feedback from the FDA in April, the company says it has worked to revise the product's usage instructions and that a new HF study was successfully completed. "However, I am surprised with the agency's other requests with regards to additional technical data from final commercial product," stated CEO Nikolaj Sørensen.Orexo noted that its filing did include technical data from pilot-scale manufacturing, and it believed that this would be sufficient for approval. Still, Sørensen said he is "confident we can address this efficiently."The market did not react negatively to the news, with the Swedish company's shares ending the day up by almost 2%.OX124 is based on Orexo's amorphOX drug delivery platform and is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl. Other naloxone-based products already available in the US include Emergent BioSolutions' Narcan and Harm Reduction Therapeutics' RiVive, both of which are over-the-counter nasal sprays that were approved by the FDA last year.

HERPEN, The Netherlands, Feb. 8, 2024 /PRNewswire/ -- Orexa B.V., a Dutch life sciences company that is developing a new medicine that increases food intake and supports health in patients, announces that the first patient has been dosed in a Phase 2 clinical trial in the prevention of postoperative ileus. The trial investigates whether patients who undergo major abdominal surgery will develop less gastrointestinal disturbances and will recover more quickly. Study 2022-503113-31-00-IN-002 (EudraCT number) is a multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of Orexa's lead compound ORE-001. It will enroll 100 to 120 female patients who undergo gynecologic surgery requiring longitudinal laparotomy. The study runs at multiple centers in Germany with lead investigator Prof. Alexander Mustae from Universitätsklinikum Bonn (UKB). The first patient is dosed on 11 January 2024 in Bonn. "This is a major milestone for a company like Orexa to start its first clinical Phase 2 study," says Prof. Ard Peeters. He continues: "Finally we will be able to test our drug in patients. This first study is in a group where we can possibly prevent a so-called postoperative ileus. This is a serious complication, which affects up to 50% of patients in several patient groups and leads to patients being unable to eat and therefore recovering more slowly, resulting in prolonged hospitalization." About Orexa: Orexa is developing a drug that increases food intake. The markets where increased food intake can lead to substantial health benefits are large. Orexa focuses primarily on the recovery of patients who have undergone surgery, anorexia patients and people with malnutrition (sarcopenia / cachexia). The company is founded in 2016 and is based in Herpen (North Brabant), The Netherlands. For more information, see .