Pfizer, Acura get FDA OK for Oxecta
NEW YORK — The Food and Drug Administration has approved a medication designed to treat acute and chronic moderate to severe pain, where the use of an opioid analgesic is suitable.
Pfizer and Acura Pharmaceuticals said that their drug Oxecta (oxycodone HCl, USP tablets) is the first tamper-resistant medication designed to deter abuse and misuse with Aversion technology, which is being licensed by Pfizer from Acura.
Opioid medications are an important treatment option for patients with moderate to severe pain who are not adequately managed by other pain treatments, Pfizer and Acura said, noting that abuse and misuse of opioids is a serious public health issue.
"We are excited to be partnered with Pfizer to bring Oxecta to patients who need opioids to manage their pain," Acura’s interim president and CEO Robert Jones said. "Acura is focused on developing technologies that are intended to potentially deter abuse and misuse."
ProStrakan receives FDA approval to market Rectiv
GALASHIELS, Scotland, and BEDMINSTER, N.J. — ProStrakan has received approval from the Food and Drug Administration to market an ointment designed to treat moderate to severe pain associated with chronic anal fissures.
The drug maker, which is a subsidiary of Kyowa Hakko Kirin, said that it received regulatory approval for Rectiv (nitroglycerin) ointment 0.4%. Rectiv currently is the only FDA-approved prescription product for patients with this condition. ProStrakan expects Rectiv to be available in the United States in first quarter 2012.
Approximately 700,000 people in the United States receive a diagnosis or treatment for anal fissures each year. An anal fissure is a small tear in the skin that lines the anus and can occur in a number of ways, such as passing large or hard stools, straining during a bowel movement or following an episode of diarrhea. When an anal fissure occurs, it typically causes severe pain and bleeding with bowel movements.
The product is marketed under the name Rectogesic in the European Union and already is approved in the EU and marketed by ProStrakan in all major European countries.
Omnicare adds Mark Emmert, Barry Schochet to board of directors
COVINGTON, Ky. — Omnicare has added two members to its board of directors.
The company said that Mark Emmert and Barry Schochet will serve as independent directors. Emmert serves as president of the National Collegiate Athletic Association, while Schochet serves as president and CEO of BPS Health Ventures, a healthcare consulting and investment firm.
"We are very pleased to welcome Mark and Barry to Omnicare’s board of directors," Omnicare chairman of the board James Shelton said. "We have instituted a number of recent changes to the corporate governance structure, and we believe the addition of two new independent directors reflects our continued progress in this area. Mark and Barry bring to our board a broad range of healthcare and leadership experience, which we believe will serve Omnicare well in the years ahead."