Navigation Links
Neurim Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results of Piromelatine for the Treatment of Insomnia
Date:2/17/2013

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 EranS@Neurim.com  



'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... , May 25, 2016  Zymo Research ... for their new reference materials that help researchers ... sample collection to analyses. The rapid growth of ... for researchers to have standard methods to improve ... generated. Biases inherently exist at every step of ...
(Date:5/25/2016)... May 25, 2016  Granger Diagnostics today announced immediate ... wounds and infections. This test ensures discovery of ... viruses. The test requires only a simple swab of ... David G. Bostwick , MD, Chief Medical ... wound healing: "We are excited to make available, ...
(Date:5/25/2016)... PUNE, India , May 25, 2016 /PRNewswire/ ... Pipeline Review, H1 2016"market research report that provides ... complete with comparative analysis at various stages, therapeutics ... route of administration (RoA) and molecule type, along ... releases. It also reviews key players involved in ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... 27, 2016 , ... More than a third of American adults are considered ... surgery has received increased attention in recent years, as an article published ... weight loss, most people are familiar with the basic requirements of maintaining a healthy ...
(Date:5/27/2016)... ... 27, 2016 , ... With over 60 percent of acute stroke survivors being ... product to aid in the rehabilitation process has steadily increased. Ekso Bionics had been ... hemiplegia due to stroke. , Ekso Bionics has now received clearance from the U.S. ...
(Date:5/27/2016)... NY (PRWEB) , ... May 27, 2016 , ... ... world, this installment is bolstered by inspiring human interest stories, courtesy of leaders ... developing trends and tech within the industry, from leading advocates and associations—namely Jones ...
(Date:5/26/2016)... , ... May 26, 2016 , ... There are many ... Dog and Sausage Council (NHDSC) suggests that Americans prefer their dogs straight off the ... percent say grilling is their favorite way to cook a hot dog, far outpacing ...
(Date:5/26/2016)... ... , ... Connor Sports, through its Connor Cares initiative, will continue ... Catchings Legacy Tour that will commemorate the Indiana Fever legend’s hall-of-fame career and ... forms and levels of the game, Connor Sports has committed to a significantly increased ...
Breaking Medicine News(10 mins):