Posts Tagged ‘drug’

Forum Pharmaceuticals announced that the FDA has granted Fast Track designation to encenicline for the treatment of cognitive impairment in schizophrenia.

Forum recently completed patient enrollment for the COGNITIV SZ phase 3 clinical trial program which includes two randomized, double-blind, placebo-controlled studies. The program is evaluating the safety and efficacy of two oral doses of once-daily treatment with encenicline as a pro-cognitive treatment compared to placebo when added to chronic, stable, atypical antipsychotic therapy in people with schizophrenia.

Primary endpoints of the trials include effect on cognitive function and effect on clinical function. The two global 26-week trials enrolled a total of more than 1,500 patients at approximately 200 clinical sites.

Encenicline is an orally administered, selective, and potent agonist of the alpha 7 receptor found in hippocampal and cortical neurons involved in cognition.

In a phase 2 trial, which was sponsored by Forum and results of which were released in March, 319 schizophrenia patients were randomized to receive either encenicline in one of two doses daily, or a placebo, for 12 weeks.

Patients in both encenicline dose groups showed significant cognitive improvement based on various measures, according to a presentation made at the 15th International Congress on Schizophrenia Research. In a subset of 154 patients, the improvement was greater in the higher-dose group (0.9 mg) than the lower-dose cohort (0.27 mg).

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Possession of ecstasy and other drugs is currently legal in Ireland, but only for a day, after a court ruling on Tuesday morning.

A written judgment released by the Republic’s court of appeal said part of the Misuse of Drugs Act 1977, which allows certain substances to be controlled, is unconstitutional, meaning all government orders banning substances such as ecstasy and magic mushrooms are void – and it is not an offence to possess them.

Specifically, the court found that the act was being added to via ministerial order and without consulting the Oireachtas (both houses of the Irish parliament) and deemed this unconstitutional.

The appeal court’s ruling came in favor of a man who was prosecuted for possession of methylethcathinone, which was among a number of substances put on the controlled drugs list in 2010.

Stanislav Bederev denied the charge of having the substance for supply in 2012, and then brought a high court challenge in Dublin seeking to stop his trial, claiming that additions to the 1977 act were unconstitutional.

Bederev’s legal team argued it was not lawful to put the substance on the controlled drug list because there are no principles and policies guiding the introduction of such rules – and specifically no consultation with the Irish parliament.

The Irish government now has to force through emergency legislation in its parliament on Tuesday evening in response to the ruling.

The emergency law won’t come into place until the Republic’s second chamber, the Seanad, endorses the legislation. Following that the country’s president, Michael D Higgins, will have to gave his approval.

http://www.theguardian.com/world/2015/mar/10/irish-es-are-smiling-ecstasy-drugs-temporarily-legal-in-ireland