Content about Clinical trial

NEW YORK — A Pfizer painkiller appears to produce a much less positive experience for recreational drug users when crushed than when administered whole, according to results of a post-market clinical study program.

NEW YORK — A drug made by Pfizer shows "significant" benefit to patients with restless legs syndrome, according to results of a late-stage clinical trial announced Friday.

The drug maker said Lyrica (pregabalin) produced statistically significant improvements in patients with RLS compared with placebo and pramipexole after 12 weeks of treatment. In the phase-3 study, A0081186, 300 mg of Lyrica, 0.25 mg of pramipexole, 0.5 mg of pramipexole or placebo was given to patients on a daily basis.

RYE, N.Y. — A drug in late-stage clinical trials appears to treat the symptoms of autism, the drug's developer said Wednesday.

Curemark announced results of the phase-3 trial of CM-AT in children ages 3 to 8 years. The company said the drug had a statistically significant effect on symptoms of autism compared with placebo. The Food and Drug Administration has granted the drug fast-track status, which it does for investigational drugs to treat serious or life-threatening conditions that may address unmet medical needs.

TARRYTOWN, N.Y. — Bayer HealthCare and Regeneron Pharmaceuticals have started a late-stage clinical trial in China to evaluate a drug for eye disorders, the companies said Monday.

The drug makers announced the start of the phase-3 "SIGHT" trial of Eylea (aflibercept) injection for the treatment of the neovascular form of age-related macular degeneration, also known as wet AMD. The companies said the trial, which will include about 300 patients, will be the largest retinal trial conducted in China.

SILVER SPRING, Md. — A drug widely used to treat breast cancer is not safe or effective, the Food and Drug Administration said Friday.

LONDON — GlaxoSmithKline announced the results from the first of eight phase-3 clinical trials that examined the efficacy of albiglutide in the treatment of Type 2 diabetes.

The Harmony 7 trial was a 32-week, head-to-head, open-label, noninferiority study that compared albiglutide, an investigational once weekly glucagon-like peptide-1 agonist, with once-daily liraglutide. According to the results, patients administered GSK's drug saw a 0.78% reduction in HbA1C, while patients administered liraglutide saw a 0.99% reduction in HbA1C.

NEW YORK — AstraZeneca and Targacept released results of the first of four phase-3 clinical trials that investigated the efficacy and tolerability of a drug that could serve as an adjunct therapy to major depressive disorder patients that had an inadequate response to initial antidepressant therapies.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved changes to the labeling of a cancer drug made by Takeda Pharmaceuticals, the drug maker said.

Takeda and Millennium, the Japanese drug maker's cancer-drug subsidiary, announced Tuesday that the FDA approved a supplemental new drug application for the injectable multiple myeloma drug Velcade (bortezomib) that updates its label to include additional data from a clinical study showing that the drug extended patients' survival time.

OSAKA, Japan — Takeda Pharmaceuticals has started a late-stage clinical trial program for a drug to treat Type 2 diabetes, the drug maker said.

CHICAGO — A new study has found that a recently approved drug for HIV produces fewer unpleasant side effects during the first three months of therapy than the standard treatment, according to published reports.

CRANBURY, N.J. — GlaxoSmithKline and Amicus Therapeutics have started a late-stage clinical trial for a drug to treat a rare genetic disorder, the companies said.

GSK and Amicus announced the start of a second phase-3 trial of Amigal (migalastat hydrochloride) for Fabry disease, a rare lysosomal storage disorder that affects between 5,000 and 10,000 people worldwide. The market for Fabry disease has long been dominated by Genzyme, a subsidiary of French drug maker Sanofi that makes the biologic drug Fabrazyme (agalsidase beta).

EAST BRUNSWICK, N.J. — Patients with gout taking a drug made by Savient Pharmaceuticals experienced "significant" improvements, according to results of two late-stage clinical trials published in the Journal of the American Medical Association.