Latest news with #sodiumoxybate
Medscape
11 hours ago
- Health
- Medscape
EMA Reviews Alcohol Dependency Drug After French Concerns
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced it will review the use of medicines containing sodium oxybate, a drug used in narcolepsy, in people with alcohol dependency. The review comes at the request of the French Medicines Agency and has been initiated under Article 31 of Directive 2001/83/EC. This procedure is used to address concerns over the safety or benefit-risk balance of a medicine or a class of medicines; to resolve disagreements between member states on issues related to the authorization of medicines; or to give an opinion on an issue of Europe-wide interest so that the agency can make a recommendation for a harmonized position across the EU. The European Commission, any member state, or the company that markets the medicine can initiate a referral. In a referral, the European Medicines Agency (EMA) is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the European Union. It involves the matter being referred to the Pharmacovigilance Risk Assessment Committee (PRAC) after due notice to the EMA, all member states, and the European Commission. Narcolepsy Indication Sodium oxybate (Xyrem) is the sodium salt of gamma-hydroxybutyric acid. As an oral solution (500 mg/mL), it is indicated for the treatment of narcolepsy with cataplexy in adult patients, adolescents, and children from the age of 7 years. The drug is a central nervous system depressant believed to act by attaching to brain cell receptor molecules to promote delta (slow) brain waves and nighttime sleep. When taken at bedtime, Xyrem increases sleep depth and length, reducing the number of sleeping periods during the day and improving symptoms of narcolepsy. Because of the drug's potential for abuse, it can only be obtained with a special prescription, and treatment should be initiated and maintained under the guidance of a doctor with experience in treating sleep disorders. Doctors are advised to check for a history of or susceptibility to drug abuse before treatment, and to monitor for misuse and abuse during treatment. Approved for Alcohol Abuse in Austria and Italy The drug has also been suggested to reduce pain and improve function in fibromyalgia, but the EMA said the data were insufficient to support its use for this in the European population. However, sodium oxybate is also approved in Italy and in Austria, under the name Alcover, to treat alcohol dependence and alcohol withdrawal syndrome. It is this use that the review will examine. The EMA has confirmed the positive benefit-risk profile of the treatment as prescribed in Italy and Austria. France, however, despite having a high prevalence of alcohol problems, has resisted its use for this purpose. Trials have suggested that sodium oxybate can rapidly alleviate symptoms of alcohol withdrawal syndrome and was at least as effective as diazepam and clomethiazole. It can also be used in the maintenance of abstinence in alcohol-dependent patients, in whom it is reportedly as effective as naltrexone or disulfiram. Because existing approved medications are only modestly effective, there is a pressing need for effective treatments with an alternative mode of action, particularly in patients with very high consumption levels. Sodium oxybate also has a favorable safety profile. However, studies in alcohol use disorder have been limited and further investigations have been recommended.
Reuters
11 hours ago
- Health
- Reuters
EU to review some drugs containing sodium oxybate
June 20 (Reuters) - The European Union's medicine regulator said on Friday it has begun a review of some medicines that contain sodium oxybate and are used to treat alcohol withdrawal syndrome. Sodium oxybate is an active ingredient that works by calming the activity of certain cells in the central nervous system and is also used to treat narcolepsy.
Yahoo
31-05-2025
- Business
- Yahoo
Avadel Pharmaceuticals plc (AVDL) Showcases LUMRYZ Success with 14 Abstracts, 4 Oral Presentations at SLEEP 2025
Avadel Pharmaceuticals plc (NASDAQ:AVDL) announced it will present 14 new abstracts, including four oral presentations, at SLEEP 2025, highlighting significant advances for LUMRYZ, its once-at-bedtime sodium oxybate treatment for narcolepsy. Interim results from the real-world REFRESH study showed that patients switching from twice-nightly oxybate to LUMRYZ experienced clinically meaningful improvements in excessive daytime sleepiness (EDS), with many achieving normal Epworth Sleepiness Scale (ESS) scores. A scientist in a labcoat examining a vial of experimental biopharmaceuticals. Additional analyses from the pivotal Phase 3 REST-ON trial revealed that even those with the most severe baseline sleepiness saw their ESS scores normalize after 13 weeks on LUMRYZ, and the therapy did not worsen sleep apnea. Further data demonstrated a reduction in distressing hallucinations and improvement in sleep-related eating disorder (SRED) symptoms after switching to LUMRYZ. Long-term tolerability was underscored, with only 4% discontinuing due to side effects. Avadel Pharmaceuticals plc (NASDAQ:AVDL) emphasized that LUMRYZ, FDA-approved for adults and children aged 7 and older, offers a major benefit over traditional oxybate by eliminating the need for middle-of-the-night dosing, supporting better sleep continuity and patient care. With these compelling results, Avadel Pharmaceuticals plc (NASDAQ:AVDL) continues to solidify its leadership in innovative narcolepsy treatments. While we acknowledge the potential of AVDL to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than AVDL and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Sign in to access your portfolio
