Content about Clinical trial

SAN DIEGO — The Food and Drug Administration has accepted a regulatory filing from Optimer Pharmaceuticals for a drug to treat bacterial infections.

Optimer announced Monday the FDA’s acceptance of its approval application for fidaxomicin for treating clostridium difficile infection, or CDI. CDI is a colon infection that is a particular problem in hospitals, long-term care centers and in the broader community. It is estimated to affect more than 700,000 people per year. The agency has granted the application priority review and expects to finish its review by May 30.

NEW YORK — A drug for major depressive disorder worked better than placebo, according to results of a late-stage clinical trial announced Thursday.

U.S. drug maker Forest Labs and French drug maker Pierre Fabre Medicament said that while the overall difference between patients treated with levomilnacipran and those treated with the placebo was not statistically significant, the drug consistently demonstrated improvement relative to the placebo over the course of the phase-3 trial.

POINT RICHMOND, Calif. — Transcept Pharmaceuticals has resubmitted its regulatory application for a drug to treat insomnia to the Food and Drug Administration, following a previous denial of approval by the agency, the drug maker said Tuesday.

Transcept sent in its application for Intermezzo (zolpidem tartrate), a pill placed under the tongue for treating patients who awake in the middle of the night and have difficulty falling asleep again.

CLINTON, N.J. — The Food and Drug Administration has extended by six months the market exclusivity of a lung disease drug for use in children.

Drug maker Ikaria said Wednesday that the FDA had extended pediatric exclusivity period for the drug Inomax (nitric oxide) from January 2013 to July 2013.

Ikaria said the extension was based on results of a clinical study of the drug in preterm infants with bronchopulmonary dysplasia, a serious condition that results from lung injury.

WILMINGTON, Del. — The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.

The agency sent AstraZeneca a complete response letter requesting additional analyses of data from a clinical study of Brilinta (ticagrelor), but did not request additional studies. The drug is designed to treat acute coronary syndromes.

A complete response letter means that the FDA has completed its review of a drug application, but issues remain that preclude final approval.

INDIANAPOLIS — Eli Lilly is suspending a late-stage clinical trial of a cancer drug amid safety concerns, the drug maker said Monday.

The company had been conducting a phase-3 trial of the pharmaceutical drug tasisulam as a second-line treatment for patients with melanoma whose cancer could not be removed or had spread to other parts of the body. Melanoma, the deadliest form of skin cancer, is diagnosed in 68,000 people in the Untied States every year, according to the American Cancer Society.

NEW YORK — Drug maker Keryx Biopharmaceuticals got promising results from a late-stage clinical trial of a drug for treating elevated phosphate levels, also known as hyperphosphatemia, in patients on kidney dialysis, the company said Tuesday.

In a phase-3 trial, Zerenex (ferric citrate) significantly reduced phosphate levels in patients with end-stage kidney disease on dialysis.

JERUSALEM — An investigative treatment for allergies made by Teva Pharmaceutical Industries appears to work, according to results of a late-stage clinical trial released Monday.

Teva said phase-3 data from a study of Qnaze HFA (beclomethasone dipropionate), designed to be inhaled through the nose, was effective in treating patients with seasonal allergic rhinitis, while safety results were similar to those for placebo. Data from the study were presented at the annual meeting of the American College of Allergy, Asthma & Immunology in Phoenix.

SAN DIEGO Two drug makers conducting a late-stage clinical trial of a drug for treating overweight and obese patients said the drug produced significant weight loss in patients with Type 2 diabetes.

Arena Pharmaceuticals and Eisai reported results of the one-year “BLOOM-DM” phase-3 trial of the drug lorcaserin, showing that a significant number of patients lost 5% to 10% of their weight by the end of the trial. Patients taking the drug also showed improvements in blood sugar levels, compared with those taking placebo.

NEW YORK Patients with rheumatoid arthritis derive about as much benefit from a weekly injection of a biotech drug made by Bristol-Myers Squibb for the disease as they do from receiving it via IV on a monthly basis, according to late-stage clinical trial data released Monday.

WASHINGTON Nearly 100 drugs are in development for treating Alzheimer’s disease, according to a new report by the main lobby for the pharmaceutical industry.

The Pharmaceutical Research and Manufacturers of America said 98 medicines for dementia, mostly Alzheimer’s, were in clinical trials or under review by the Food and Drug Administration.

WASHINGTON The Food and Drug Administration should ensure patient access, safety and efficacy; create a transparent and scientific regulatory structure; and enable innovation and competition when creating regulations governing follow-on biologics, according to testimony released in advance of an FDA hearing by a drug lobbying group.