Neurim Pharmaceuticals announces clinical approval for insomnia medication in elderly patients
SEATTLE Neurim Pharmaceuticals announced that Circadin in 2-mg strength showed long-term efficacy and safety in elderly patients during a large-scale phase three study.
Circadin is a well-known prolonged-release melatonin used to treat primary insomnia, described by poor quality in sleep in patients over 55 years. The drug was approved by the European Commission pharmaceutical regulatory agency and the Israeli Ministry of Health for short-term treatment after clinical studies showed improvement in patient’s sleep quality, sleep induction and next day alertness and functioning.
The study based on more than 790 insomnia patients ages 18 to 80 showed six months of continuous treatment with Circadin is both safe and efficacious.
The results were announced in the Late Breaking Abstracts session of SLEEP 2009, the 23rd Annual Meeting of the Associated Professional Sleep Societies in Seattle, Wash.
Senate to vote on drug importation measure
WASHINGTON U.S. Sen. Byron Dorgan, D-N.D., has dropped his proposal to add the importation of cheaper medicines from other countries to a tobacco legislation.
Dorgan claims that under the amendment, the Food and Drug Administration would be given the power to oversee packaging, marketing and manufacturing of cigarettes and other tobacco products, Reuters reported. Additionally, U.S.-licensed pharmacies and drug wholesalers would also be allowed to import FDA-approved medicines from Canada, Europe and a few other areas for cheaper prices.
The Senate will consider the drug issue separately, Reuters said.
President Barack Obama has asked Congress for $5 million for the FDA to get started. Despite presidental backing, drugmakers are unhappy with Dorgan’s bill, claiming that with importation comes the risk for counterfeit drugs.
The tobacco bill passed the Senate on Monday with a 61-30 vote and proceeds to legislation later this week.
KV Pharmaceuticals, Purdue Pharma settle OxyContin dispute
ST. LOUIS A generic drug company has settled a dispute with a branded drug company concerning the painkiller OxyContin.
St. Louis-based KV Pharmaceutical Co. announced Tuesday that it had entered a settlement agreement with Stamford, Conn.-based Purdue Pharma in a patent infringement lawsuit that Purdue filed against KV.
Under the terms of the agreement, KV agreed that Purdue’s patents for OxyContin (oxycodone hydrochloride) are valid, enforceable and infringed. In exchange, Purdue granted KV limited rights to sell generic controlled-release oxycodone hydrochloride tablets in the United States for an unspecified period of time.