Tag Archives: GABA

Suvorexant, New Kind Of Sleeping Pill, Doesn’t Cause Side Effects In Animal Studies

By The Huffington Post News Editors

* Findings suggest drug may not impair memory, attention
* Merck’s sleep drug now before FDA
By Julie Steenhuysen
CHICAGO, April 3 (Reuters) – A study in rats and monkeys suggests an experimental Merck & Co sleep drug may help induce sleep without causing the memory loss and attention problems sometimes seen in the commonly used drugs Ambien and Lunesta, company researchers said on Wednesday.
Experiments in animals suggest Merck’s sleep drug Suvorexant, now before the U.S. Food and Drug Administration, may avoid these side effects, the company said.
Insomnia affects about 10 percent of U.S. adults, and roughly a third of these individuals take drugs to help them sleep. Most sleep aids, including Sanofi’s Ambien or Sunovion Pharmaceuticals’ Lunesta, act on a key neurotransmitter in the brain called GABA.
“These treatments work by forcing the brain to go to sleep,” said study leader Jason Uslaner of Merck in an interview on the website of Science Translational Medicine, which published the study.
GABA receptors are important to many brain regions, including those important for cognition, which is likely why common sleep aids can cause memory loss and attention problems.
“When you hit those, you don’t just hit the sleep system,” John Renger, executive director and head of neruoscience basic research at Merck and one of the study’s authors, said in a telephone interview.
Suvorexant is part of a class of drugs called Dual Orexin Receptor Antagonists or DORAs, which work by blocking chemical messengers called orexins. Orexins are responsible for keeping people awake. Levels of this compound rise during the day and fall at night.
Orexins originate in a specific region of the hypothalamus, so targeting them may have less impact on other brain functions, Renger said.
For this study, the team wanted to find out what would happen if someone is awakened on this drug and has a …read more
Source: FULL ARTICLE at Huffington Post

BioLineRx Announces Results from Interim Analysis of Phase II/III CLARITY Trial of BL-1020 for Schiz

By Business Wirevia The Motley Fool

Filed under:

BioLineRx Announces Results from Interim Analysis of Phase II/III CLARITY Trial of BL-1020 for Schizophrenia

Management call scheduled for Wednesday, March 20 th , at 11:00 a.m. EDT

JERUSALEM–(BUSINESS WIRE)– BioLineRx (NAS: BLRX)  (TASE: BLRX), a biopharmaceutical development company, today announced that results from a pre-planned interim analysis of the Phase II/III CLARITY trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia, indicate that the trial would not meet the pre-specified primary efficacy endpoint. After conferring with the study’s independent Data Monitoring Committee (DMC), the Company has decided to discontinue the CLARITY study. No additional patients will be enrolled in the trial.

“These disappointing results underscore the difficulty of treating cognition in schizophrenia, which remains an unmet medical need,” stated Kinneret Savitsky, PhD, Chief Executive Officer of BioLineRx. “We would like to thank the patients and investigators for their participation and engagement in the study. While we certainly would have preferred to see a positive outcome on this trial, the decision to perform the interim analysis, without waiting until the end of the study, provides us with the opportunity to allocate additional resources to our other projects in order to accelerate their development. This confirms the advantage of our business model, which is based on a broad pipeline with a number of compounds, at different stages of development, and for multiple indications.”

As a result of the CLARITY study termination, the Company anticipates that planned research and development expenses will decrease for the remainder of 2013 and part of 2014 by approximately $6 to $7 million, thus allowing the Company’s current cash reserves of approximately $28 million to fund its expected operations into 2015. The Company expects to meet a number of significant clinical milestones related to other pipeline assets in the next 12-18 months.

About Phase II/III CLARITY Study Interim Analysis

The interim analysis included data on 230 subjects, of which 168 were evaluable for analysis on the primary (six-week) cognitive endpoint. The analysis indicated no efficacy of BL-1020, in comparison to Risperidone, relative to the cognitive primary and secondary (12-week and 24-week) endpoints. However, in several statistical parameters specified in the statistical analysis plan (SAP), positive trends in cognition were observed. The Company intends to perform a complete analysis of the un-blinded study data on all patients enrolled to date in order to ascertain …read more
Source: FULL ARTICLE at DailyFinance