adrenergic receptor

OX640 is a nasal rescue medication with powder-based epinephrine for the treatment of allergic reactions (incl. anaphylaxis) and is based on the proprietary AmorphOX® technology The clinical study, OX640-002, evaluated both pharmacokinetic and pharmacodynamic effects of OX640 in subjects with and without allergic rhinitis OX640 treatments achieved clinically relevant plasma levels of epinephrine more rapidly than the intramuscular reference product Absorption from OX640 under allergic rhinitis conditions was significantly faster than under normal conditions, supporting rapid onset of effect also in patients with airway symptoms. Uppsala, Sweden – January 10, 2025 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces positive topline results from the clinical study OX640-002. The study evaluated the performance in subjects with and without allergic rhinitis when treated with Orexo´s nasal rescue medication including powder-based epinephrine, OX640. The study was a cross-over study in 30 subjects assessing absorption and pharmacodynamic effects of epinephrine from two doses of OX640, with one of the doses also administered during ongoing allergic rhinitis symptoms. Exposure was compared to a commercial intramuscular injection. Topline data analysis demonstrates that OX640 treatments achieved mean epinephrine plasma levels associated with clinical efficacy more rapidly than the intramuscular injection, with dose-dependent exposure levels. Absorption under allergic rhinitis conditions was significantly faster than under normal conditions, supporting rapid onset of effect also in patients with significant airway symptoms. OX640 formulations typically produced more pronounced increases in blood pressure and heart rate than the intramuscular injection, which are key effects for treatment of anaphylaxis. Systemic safety was in line with the known pharmacology of epinephrine and local effects were transient and tolerated. There were no severe or serious adverse events. Robert Rönn, SVP and Head of R&D, said: “We are pleased with the outcome of the study which further support the utility of our OX640 epinephrine nasal powder for treatment of anaphylaxis, even in case of allergic rhinitis symptoms. Importantly, the study results allow us to decide on the final commercial formulation and dose, which is critical to advance the project towards regulatory approval. The data further reinforces our view that OX640 has the potential to be a unique and differentiated needle-free epinephrine product.” For further information please contact: Nikolaj Sørensen, President and CEO Lena Wange, IR & Communications Director Robert Rönn, SVP and Head of R&D Tel: +46 (0)18 780 88 00 E-mail: ir@orexo.com About Orexo Orexo is a Swedish pharmaceutical company with 30 years of experience developing improved pharmaceuticals based on proprietary formulation technologies that meet large medical needs. On the US market, Orexo provides innovative treatment solutions for patients suffering from opioid use disorder and adjacent diseases. Products targeting other therapeutic areas are developed and commercialized worldwide with leading partners. Total net sales in 2023 amounted to SEK 639 million, and the number of employees to 116. Orexo is listed on Nasdaq Stockholm's main list and is available as an ADR on OTCQX (ORXOY) in the US. For more information on Orexo, visit www.orexo.com. Follow Orexo on X, LinkedIn, and YouTube. About AmorphOX® Orexo’s proprietary drug delivery platform, AmorphOX, is a powder made up of particles which are built using a unique combination of a drug, carrier materials and, optionally, other ingredients. The particles are presented as an amorphous composite of the various ingredients providing for excellent chemical and physical stability, as well as rapid dissolution. The technology works for a broad scope of active ingredients and has been validated in several human clinical studies showing rapid and extensive drug exposure. About study OX640-002 The study was a 4-period cross-over study in 30 otherwise healthy subjects with seasonal allergic rhinitis. The study was conducted off allergy season with no ongoing allergy symptoms in subjects. Epinephrine plasma levels, blood pressure and heart rate were collected after administration of two different doses of OX640 and 0.3 mg intramuscular epinephrine. In one treatment period, one of the OX640 doses was administered following nasal administration of allergens, producing acute allergic rhinitis symptoms in the subjects. The information was submitted for publication at 8.00 am CET on January 10, 2025.

Canada and United Kingdom represent two of the largest markets within the ALK portfolio with plans to expand filings of neffy (epinephrine nasal spray) 2 mg in other key global regions Jan. 06, 2025 -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced today that ARS Pharma has filed for approval of neffy® (epinephrine nasal spray) 2 mg in Canada and the United Kingdom (U.K.), where it will be marketed as EURneffy®, on behalf of its licensing partner, ALK- Abelló A/S (ALK). neffy was recently approved in the U.S. for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.). In November 2024, ARS Pharma announced a licensing agreement providing ALK with exclusive rights to commercialize neffy in Europe, Canada, United Kingdom and certain other geographies outside of the U.S. “Building upon the approval of neffy in the U.S. and Europe for the emergency treatment of severe allergic reactions, we are committed to helping facilitate access to this life-saving treatment worldwide,” says Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma. “With submission in Canada and the U.K., ARS Pharma now has approval or has filed for approval in jurisdictions comprising more than 98 percent of the current world market for epinephrine. We look forward to hearing from the regulatory agencies following their review of the applications.” Under the terms of the licensing agreement, ARS Pharma received an upfront payment of $145 million and is eligible to receive up to an additional $320 million in regulatory and sales milestones, as well as tiered, double-digit royalties in the teens on net sales in licensed geographies. ARS Pharma will be responsible for manufacturing and supplying neffy to ALK. ARS Pharma retains all U.S. rights for neffy and has existing licensing partnerships in China, Japan, Australia and New Zealand with Pediatrix Therapeutics, Alfresa Pharma, and CSL Seqirus, respectively. ARS Pharma is also evaluating its intranasal epinephrine technology for the treatment of acute flares in patients with chronic urticaria, with plans to begin a Phase 2b clinical trial in early 2025. The license agreement with ALK also provides them exclusive rights for any new indications in the licensed territories. neffy is an intranasal epinephrine product for patients with Type I allergic reactions due to insect stings or bites, foods, medicinal products, other allergens, as well as idiopathic or exercise induced anaphylaxis that could lead to life-threatening anaphylaxis. Type I allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency. ARS Pharmaceuticals is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy® 2 mg (trade name EURneffy® in the EU) (previously referred to as ARS-1), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, other allergens, as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visit www.ars-pharma.com. The content above comes from the network. if any infringement, please contact us to modify.

THURSDAY, Jan. 2, 2025 -- Gemtesa (vibegron) has been approved by the U.S. Food and Drug Administration for men with overactive bladder (OAB) symptoms receiving pharmacologic therapy for benign prostatic hyperplasia (BPH), according to a press release published by Sumitomo Pharma. Gemtesa, a β 3 adrenergic receptor agonist, dosed once daily (75 mg), has been approved for men with OAB symptoms, including urinary incontinence, urgency, and urinary frequency, who are receiving pharmacologic treatment for BPH. The approval was based on results from a 24-week phase 3 study of Gemtesa versus placebo in about 1,100 men with OAB symptoms receiving pharmacologic therapy for BPH. All coprimary end points at week 12 were met, with significant reductions from baseline seen in the average number of micturition episodes per day and in the average number of daily urgency episodes with Gemtesa versus placebo. In addition, at 12 weeks, there was a reduction in instances of urge urinary incontinence episodes per day. Adverse reactions of hypertension and urinary tract infection exceeding the placebo rate occurred in ≥2 percent of patients treated with Gemtesa. "The FDA's expanded approval of Gemtesa is an important milestone for the men with unresolved symptoms of OAB while being treated for BPH, which underscores our urgency to deliver for those affected by conditions with unmet need," Tsutomu Nakagawa, Ph.D., president and chief executive officer of Sumitomo Pharma America Inc., said in a statement. Approval of Gemtesa was granted to Sumitomo Pharma. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.