FDA gives Wockhardt tentative approval for bipolar, schizophrenia drug
PARSIPPANY, N.J. — Indian drug maker Wockhardt has received tentative approval from the Food and Drug Administration for a generic version of a Pfizer psychiatric drug.
Wockhardt announced the tentative approval for ziprasidone hydrochloride in the 20 mg, 40 mg, 60 mg and 80 mg strengths, used to treat bipolar disorder and schizophrenia, and the company plans to launch the drug on Sept. 2, 2012.
The drug is a generic version of Pfizer’s Geodon, which has a market size of about $1.3 billion, according to IMS Health. Tentative approval means that the generic drug meets the conditions for FDA approval, but the agency can’t approve it because the branded drug’s patent has not yet expired. One of Geodon’s patents expired in March 2012, and another expires on Sept. 1 of this year, while two more expire in 2018 and 2019, according to FDA records. The drug will lose data exclusivity in November 2012.
No comments found
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.
No comments found
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."