Navigation Links
Neurim Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results of Piromelatine for the Treatment of Insomnia

ZURICH, February 18, 2013 /PRNewswire/ --

Neurim Pharmaceuticals announced today positive results from a phase II clinical study evaluating the efficacy and safety of Piromelatine (Neu-P11), a novel investigational multimodal sleep medicine developed for the treatment of patients with primary and co-morbid insomnia. The new results are from a  recent double-blind, randomized, placebo controlled, parallel group, non-confirmatory, sleep-laboratory study. The study evaluated piromelatine compared to placebo in 120 adult primary insomnia patients ages 18 years and older.

Piromelatine 20/50mg treatment for 4 weeks resulted in statistically significant and clinically meaningful improvements relative to placebo in key  polysomnographic (PSG) parameters including Wake After Sleep Onset (WASO) (p=0.02 for both doses) and in particular WASO for the first 6 hours of sleep (WASO-6h) (p=0.0008 and p=0.04 for the 50 mg and 20 mg groups, respectively). Piromelatine 50 mg also improved Sleep Efficiency (SEF) (p=0.02), Total Sleep Time (TST) (p=0.02), Total Time Awake (TTA) (p=0.01) and time in NREM sleep (p=0.028) indicating beneficial effects on sleep maintenance. Subjective improvements relative to placebo in quality of sleep and total sleep time measured by the Pittsburg Sleep Quality Questionnaire (PSQI) were also observed, confirming the PSG findings. Piromelatine enhanced NREM sleep EEG delta power and significantly reduced beta power (p<0.05). The decrease in EEG beta activity, a marker of cortical arousal, is a physiological surrogate marker of the efficacy of Piromelatine in sleep maintenance. Piromelatine was generally safe and well tolerated, had no detrimental effects on next-day psychomotor performance (as assessed by the Digit Symbol Substitution Test (DSST)) for any dose group and no deleterious effects on sleep structure and architecture.

"Piromelatine demonstrates a good potential for the treatment of primary insomnia characterized by sleep maintenance disturbances as well as insomnia with psychiatric or medical co-morbidities" said Prof. Nava Zisapel , CSO of Neurim. The study results will be presented at the 27th Annual Meeting of the Associated Professional Sleep Societies (APSS) -Sleep 2013 meeting in Baltimore.

About Piromelatine:

Piromelatine is thought to work through a combination of MT1\MT2 (potential sleep promoting and chronobiotic effects) and 5HT1A\D (potential anxiolytic and analgesic effects) receptors agonism. All potential effects of piromelatine were demonstrated in relevant animal models. Phase-IA and IB studies of safety, tolerability, pharmacokinetics and sleep promoting activity of piromelatine demonstrated dose proportionality PK profile, good absorption and distribution, good safety & tolerability profile across a wide dose range and provided the first indication for a pharmacodynamic activity of Piromelatine on sleep maintenance with no detrimental effects on memory. 

About  Neurim Pharmaceuticals:

Neurim Pharmaceuticals Ltd., founded in 1991 is a drug discovery and development company focused on the central nervous system (CNS). It's first approved drug, Circadin® - prolonged release melatonin for insomnia is commercially available in more than 40 countries around the world.

For more information:
Eran Schenker, MD
Medical & Corporate Business Development Director
Neurim Pharmaceuticals Ltd. 27 Habarzel  St Tel-Aviv 69710 Israel
Tel: +972-3-7684914 Cell: +972-52-6689944  

SOURCE Neurim Pharmaceuticals
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Savient Pharmaceuticals to Hold First Quarter 2012 Financial Results Conference Call on Wednesday, May 9, 2012
2. Auxilium Pharmaceuticals to Present at the Deutsche Bank 37th Annual Healthcare Conference
3. Nouveau Life Pharmaceuticals (HRID) Contracts with U.S. Manufacturer to Produce New Female Supplement
4. BioElectronics Survey Indicates a Five-Fold Superior Pain Relief Compared to OTC Pharmaceuticals
5. Icahn Issues Statement Regarding Amylin Pharmaceuticals
6. Almost 50 Percent of the Glaucoma Patient Population Remains Untreated, Signifying a Vast Market for Glaucoma Pharmaceuticals, Finds Frost & Sullivan
7. Omthera Pharmaceuticals Announces Positive Top-Line Results from Phase 3 EVOLVE Study
8. Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
9. Jazz Pharmaceuticals Announces First Quarter 2012 Financial Results Conference Call On May 8, 2012
10. Inovio Pharmaceuticals Granted U.S. Patent Protection for Synthetic Vaccine for Cervical Dysplasia and Cancer
11. Avanir Pharmaceuticals To Present at Three Conferences In May
Post Your Comments:
(Date:10/13/2015)... World Thrombosis Day Interactive Infographic ...   --> World Thrombosis Day Interactive ... promote vital global awareness of thrombosis, its causes, ... the formation of potentially deadly blood clots in ... thromboembolism (VTE) - or the artery (arterial thrombosis) [1] ...
(Date:10/12/2015)... the United States . By early next year, ... the United States . By early next year, ... The University of Texas MD Anderson Cancer Center, Elekta and ... Tesla) MRI-guided linear accelerator in the United States ... a non-clinical capacity. Royal Philips (NYSE: PHG ...
(Date:10/12/2015)... , Oct. 12, 2015 ... the setbacks and the needs of the medical membrane ... of membrane devices within the different medical membrane devices ... blood microfilters/apheresis systems and membrane diagnostic devices. - Gain ... in this market. --> Use this report ...
Breaking Medicine Technology:
(Date:10/13/2015)... ... October 13, 2015 , ... ... Anik Singal's newly launched "Publish Academy" training course . Singal's new program, ... for enrollment today, and marketers around the Internet are weighing in with reviews. ...
(Date:10/13/2015)... ... 2015 , ... Scientists in Seattle and Vancouver compared the diagnostic value of ... mesothelioma. Surviving Mesothelioma has just posted an article on the new research. Click ... and the University of British Columbia found that certain genetic alterations were seen just ...
(Date:10/13/2015)... ... October 13, 2015 , ... California Southern ... Nursing. Dr. McLeod—who earned her Doctor of Nursing Practice from the renowned Johns ... spanned four decades. , Dr. McLeod’s long and successful nursing practice included a ...
(Date:10/13/2015)... ... October 13, 2015 , ... ... most people do not breathe correctly. According to T’ai Chi (also spelled “Taiji”) ... learning to breathe correctly, in concert with the 7,000 year old tradition they ...
(Date:10/13/2015)... ... October 13, 2015 , ... In an ongoing ... PediaPlex , a Southlake, Texas, child development and pediatric therapy center, is working ... military families about their options for receiving this kind of care for affected ...
Breaking Medicine News(10 mins):