Invivodata ePRO research shows efficacy of Amitiza on IBS-C
PITTSBURGH Invivodata, which provides electronic patient reported outcomes solutions and services for global clinical research, recently announced that its ePRO solutions—DiaryPRO and SitePRO—captured primary efficacy data that supported the recent Food and Drug Administration’s supplemental approval of Sucampo Pharmaceutical Amitiza 8 mcg twice daily for the treatment of irritable bowel syndrome with constipation in women 18 years of age and older.
Invivodata designed and implemented a combination of site-based and field-based ePRO data capture systems to collect efficacy data for Sucampo’s phase 2 and 3 trials of Amitiza for IBS-C treatment. Throughout the trials, researchers used SitePRO, an in-clinic solution, to determine subject eligibility. Trial subjects then used DiaryPRO, invivodata’s field-based ePRO system, to record daily assessments plus SitePRO to record weekly in-clinic assessments of disease severity and symptom relief. Throughout the trials, data collected from both systems were integrated and easily accessible to study staff on invivodata’s comprehensive ePRO management system.
“We are very pleased with invivodata’s contributions to this program and their ability to accurately capture the critical data we needed to support FDA supplemental approval of Amitiza,” said Gayle Dolecek, senior vice president of research and development at Sucampo Pharmaceuticals. “Their staff was very knowledgeable about the scientific and practical aspects of PRO data collection, and their processes were found to be regulatory compliant during an FDA audit of their systems and practices, which was an important component of this approval.”
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.