Lunesta-Lexapro study returns positive results
MARLBOROUGH, Mass. Sepracor has announced the release of a study for its sleeping drug Lunesta. The 595-patient study examined the safety and efficacy of Lunesta co-administered with Lexapro, which is commonly used in the treatment of anxiety, versus co-administration of Lexapro and placebo in patients with insomnia and co-existing generalized anxiety disorder.
Patients treated with Lunesta and Lexapro demonstrated significant improvement in all measured sleep parameters when averaged over the eight-week, double-blind period, including the primary endpoint of sleep latency (25-minute decrease in sleep onset), sleep maintenance and total sleep time (TST; 60-minute increase), compared with patients who were treated with Lexapro and placebo (11.5-minute decrease for sleep onset and 35-minute increase for TST).
The Lunesta-Lexapro co-therapy also resulted in significant patient-reported improvements from baseline in daytime symptoms of insomnia, including daytime alertness, ability to function, ability to concentrate and physical well-being compared to the Lexapro-placebo administration when averaged over the treatment period.
“The results of this study are consistent with results of other studies of Lunesta evaluating insomnia with major depressive disorder and symptoms associated with perimenopause, which have shown that improvements in sleep can have positive effects on the co-morbid condition,” said Mark H.N. Corrigan, executive vice president, research and development at Sepracor.
Ziopharm’s Palifosfamide receives orphan designation
NEW YORK Ziopharm Oncology has received orphan drug approval from the Food and Drug Administration for Palifosfamide, for the treatment of soft tissue sarcoma, according to published reports.
Ziopharm will receive seven years of exclusivity of marketing for the drug once it has been approved, as well as an accelerated review process, grant funding, tax benefits, and an exemption from other fees.
Ziopharm’s chief executive Jonathan Lewis said that the drug stands to bring in as much as $400 million in revenues annually in the U.S. alone once it is approved. “Developing drugs for rare diseases is going to become increasingly more important because more and more the way we define diseases is into smaller and smaller subsets,” said Lewis. “In addition, we are looking to develop this for other indications starting with sarcoma.”
The intravenous form of Palifosfamide is currently in phase II studies and the oral form is expected to enter Phase I studies in early 2009.
Delhaize banners offer discounted generics
LAS VEGAS Shoppers at several supermarket chains in the eastern U.S. can buy hundreds of generic drugs at a discount.
Belgian food retailer Delhaize Group is offering a generic drug discount program at several of its U.S. chains, including Nashville, Ga.-based Harveys Supermarkets, Salisbury, N.C.-based Food Lion, Tampa, Fla.-based Sweetbay Supermarkets and Scarborough, Maine-based Hannaford Bros.
Participating stores offer 30-day and 90-day supplies of hundreds of generic drugs, though Harveys only offers 90-day supplies. Sweetbay offers more than 400 drugs, including the psychiatric drug haloperidol, thyroid hormone levothyroxine and respiratory drug albuterol, charging $4 for 30-day supplies and $10.99 for 90-day supplies.