Pfizer, Medivation ‘disappointed’ in phase-3 trial results for Dimebon
NEW YORK — A drug originally developed by scientists in the Soviet Union to treat allergies and currently under investigation by Pfizer and Medivation did not yield significant results in a late-stage clinical trial of patients with Huntington disease, a disorder that leads to cognitive decline, the companies said Monday.
In the phase-3 “HORIZON” trial, Dimebon (latrepirdine) did not produce a statistically significant improvement in patients’ conditions, leading the companies to cancel the study, which had enrolled more than 400 patients. Another study, “CONCERT,” in patients with Alzheimer’s disease is ongoing.
“We are disappointed with the results of the HORIZON trial given the high unmet need in this patient population,” Medivation president and CEO David Hung said. “At this point, we will discontinue development of Dimebon in Huntington disease, including the ongoing open-label extension study.”
Sandoz gets FDA nod for Altavera
PRINCETON, N.J. — The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.
Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Altavera (levonorgestrel and ethinyl estradiol) tablets, a generic version of Duramed’s Nordette.
Branded and generic versions of Nordette had sales of about $57.4 million during the 12-month period ended in February, according to IMS Health.
Winn-Dixie utilizes Sharps Compliance’s TakeAway program
JACKSONVILLE, Fla. — Winn-Dixie on Monday announced that its pharmacy will offer specially designed medication disposal envelopes to help its customers safely dispose of unused, outdated or unwanted medications.
The specially designed TakeAway Environmental Return System envelopes, made by Sharps Compliance, offer a convenient, safe and environmentally responsible method to dispose of unused, expired or unwanted noncontrolled prescription or over-the-counter medications, the grocer stated.
"Winn-Dixie is making it easy for our customers to dispose of unwanted medications, preventing potential misuse of these medications and also preventing contamination of our lakes and rivers, many of which serve as community water supplies," stated John Fegan, Winn-Dixie VP pharmacy.
Customers can place unwanted prescription and over-the-counter medications, excluding controlled drugs, in the envelope, seal it and then drop it in the mail. The postage-paid envelope is sent to an approved treatment facility, where licensed law enforcement oversees the safe and environmentally responsible disposal process.
The TakeAway envelope solutions are available for $2.99 in all of Winn-Dixie’s 379 in-store pharmacies in Florida, Alabama, Georgia, Louisiana and Mississippi.
Controlled medications are excluded from this program because of current federal regulations.