AcelRx starts third phase-3 trial of drug for post-operative pain
REDWOOD CITY, Calif. — A drug maker that specializes in pain medications started the third late-stage trial of a drug for treating pain in patients who have undergone certain surgeries.
AcelRx Pharmaceuticals announced the dosing of the first patient in a phase-3 trial of ARX-01 (sufentanil), also called the Sufentanil NanoTab PCA System, a patient-controlled analgesic therapy designed to be placed under the tongue in patients who have undergone hip or knee-replacement surgery. The drug is designed as an alternative to treatments that involve intravenous pumps delivering morphine.
"The start of our third phase-3 clinical trial for ARX-01 is an important milestone for our lead sufentanil NanoTab development program," AcelRx president and CEO Richard King said. "The results of all three phase-3 registration studies are expected to form the basis of a new drug application for ARX-01, which we plan to submit to the [Food and Drug Administration] during the third quarter of 2013."
The study will enroll approximately 400 patients, who will receive either Sufentanil NanoTabs or placebo NanoTabs.
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J&J, GSK start phase-3 trial program for rheumatoid arthritis drug
SPRING HOUSE, Pa. — A division of Johnson & Johnson has started a late-stage clinical trial program for a drug for rheumatoid arthritis under a partnership with British drug maker GlaxoSmithKline.
Janssen Biologics, based in Ireland, said it and GSK had started phase-3 studies of CNTO 136 (sirukumab), which the companies are investigating as a treatment for adults with moderately to severely active RA. The program includes two trials, SIRROUND-T and SIRROUND-D, which will assess how well CNTO 136 reduces signs and symptoms of the disease in patients who are allergic to certain drugs used to treat the disease.
"We are focused on advancing treatment options for chronic, debilitating autoimmune diseases such as rheumatoid arthritis," Janssen Research & Development VP and head of immunology development Jerome Boscia said. "We are pleased to be collaborating with GlaxoSmithKline on the clinical development of sirukumab, a protein therapeutic that we believe may represent an important treatment option for immunological diseases in the future."
New Rembrandt Gentle White toothpaste aims to gently whiten, reduce risk of irritation
NEW YORK — Oral care brand Rembrandt is expanding its product portfolio with its new Gentle White toothpaste, which is geared toward people prone to canker sores.
It is positioned as the category’s first whitening product focused on whitening without SLS, known to cause irritation, and helps strengthen tooth enamel to prevent daily acid wear, stated Johnson & Johnson Healthcare Products Division of McNEIL-PPC.
When one’s mouth is prone to irritations like canker sores, the ingredient SLS, found in some whitening toothpastes, can trigger those irritations. Citing data from National Institute of Dental and Craniofacial Research, the manufacturer stated that 19% of adults suffer from canker sores.
The new Rembrandt Gentle White is slated to hit shelves in September.
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