Midazolam Hydrochloride

Drug-drug interaction (“DDI”) clinical studies help identify the potential for side effects, or in some cases, reduced therapeutic efficacy, that may be caused by interactions between different drugs. The market leading epidermal growth factor receptor (“EGFR”) and anaplastic lymphoma kinase (“ALK”) inhibitors for the treatment of non-small cell lung cancer (“NSCLC”) are substrates of the Cytochrome P450 (“CYP”) enzyme CYP3A, and therefore their combination with drugs that are strong inducers of CYP3A is to be avoided, or is contraindicated. As per the International Council for Harmonization (“ICH”) M12, topline results from the NXP900 DDI clinical study classify NXP900 as a weak inhibitor of CYP3A; these results support the combination strategy of NXP900 with EGFR/ALK Inhibitors in NSCLC and potentially additional combinations. July 08, 2025 -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), a clinical stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced the successful completion of a clinical DDI study in healthy volunteers for NXP900, supporting NXP900’s potential as a combination partner with leading therapies. Key Study Objective: To determine whether NXP900 is an inducer of CYP3A, and if so, to classify its induction as weak, moderate or strong as per ICH M12 guidelines Study Population: 14 healthy volunteers Key Pharmacokinetics Result: NXP900 increased the concentration of Midazolam, a known CYP3A sensitive substrate, by Key Safety Results: No serious or severe adverse events were reported in this study; diarrhea and non-infection related increases in white blood cell counts were the most common adverse events reported, all mild to moderate in intensity Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “As we’re now completing the dose escalation Phase 1a study of NXP900 in patients with advanced cancers, the data generated to date, including the preclinical and mechanistic data, the clinical safety, pharmacokinetics and pharmacodynamics data, and now the clinical DDI data, strongly support advancing NXP900 into the Phase 1b program, set to begin in the coming weeks. In the Phase 1b we plan to test the therapeutic potential of NXP900 as a single agent and in non-chemotherapy based combinations with leading EGFR and ALK drugs in patients that may derive substantial clinical benefit from treatment with NXP900, as their cancers are expected to be sensitive to inhibition of SRC/YES1.” Mr. Bentsur concluded, “We believe that NXP900’s differentiating properties, mainly the type 1.5 mechanism of action which combines potent and selective inhibition of both the kinase activity and scaffolding properties of the SRC family kinases, should translate into a wide therapeutic window, and we are excited about the future of NXP900.” Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company is currently developing two clinical-stage drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule GCN2 activator currently in a Phase 1b clinical trial for the treatment for platinum resistant, ARID1a-mutated ovarian carcinoma and in an Investigator-sponsored clinical trial for the treatment of cholangiocarcinoma. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900's unique mechanism of action enables the inhibition of both the catalytic and scaffolding functions of the SRC kinase thereby providing complete shutdown of the signaling pathway. NXP900 is currently in a Phase 1a dose escalation study. The content above comes from the network. if any infringement, please contact us to modify.

Provigil® (modafinil) and Nuvigil® (armodafinil), two of the most trusted and widely prescribed brands in the narcolepsy category, will increase Neuraxpharm's global CNS presence and support market entry into new territories including Australia BARCELONA, Spain and DÜSSELDORF, Germany, Jan. 7, 2025 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, announces today that it has acquired at the end of December 2024 Provigil® (modafinil) and Nuvigil® (armodafinil), both of which are indicated for the treatment of Excessive Daytime Sleepiness (EDS) in adults with narcolepsy. Neuraxpharm has acquired these products in most markets outside the US^. Provigil's main market is Europe, with significant sales in France, Spain and Italy. Nuvigil is present in international markets with significant sales in Australia and Mexico. Both Provigil and Nuvigil are orally administered CNS stimulants indicated to improve wakefulness and reduce Excessive Daytime Sleepiness (EDS) in adult patients with narcolepsy, both with and without cataplexy. This acquisition is in line with Neuraxpharm's strategy to grow strong CNS brands and bring them to increasing numbers of patients worldwide. It will enable entry into new territories such as Australia, where Neuraxpharm also plans to launch first-in-class multiple sclerosis treatment ublituximab (BRIUMVI®), and will furthermore reinforce Neuraxpharm's presence in Mexico, where the Company established an office in 2023. The transaction follows the acquisition from Sanofi of two established product portfolios in 2023 and the securing of a landmark partnership with TG Therapeutics also in 2023 to commercialise ublituximab outside the US*. In 2020, Neuraxpharm acquired market-leading child epilepsy treatment Buccolam® (oromucosal midazolam) from Takeda, and in September last year Neuraxpharm received a positive CHMP opinion from the European Medicine Agency to extend Buccolam's indication to include the treatment of epilepsy in adults. Dr. Jörg-Thomas Dierks, CEO of Neuraxpharm, commented: "Today's acquisition is an example of how Neuraxpharm can harness its neurology-focused approach, broad international platform and entrepreneurial capabilities to expand strong CNS brands. These two leading narcolepsy treatments will be added to our broad and growing CNS portfolio. We will leverage our specialisation and reach to grow these products in existing and new markets, thereby bringing market-leading treatments to more CNS patients with unmet needs around the world." No financial details of the transaction have been disclosed. ^ Republic of Korea, Japan, Thailand and the United States are not included in this acquisition. * Territories outside the United States, Canada, Mexico, and excluding certain Asian countries previously partnered. About the Neuraxpharm Group Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years. Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline, partnerships, and acquisitions. The company has c.1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East, and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira. Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain. For more information, please visit SOURCE Neuraxpharm WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED