Regulatory Drug Approvals

invivodata’s scientists have combined scientific and regulatory expertise, innovative technology and ePRO operational insight to capture high quality data to support labeling claims. Sponsors working with invivodata benefit from this strong scientific foundation on which invivodata’s solutions are based. Several sponsors utilizing invivodata’s ePRO systems have collected primary endpoint data used in at least 14 successful drug approvals – including the first NDA granted using primary data collected on an eDiary platform.

Some examples of successful submissions which included data collected with invivodata’s DiaryPRO system are:

Allergan, Inc. – Industry’s First FDA Approval

The U.S. Food and Drug Administration (FDA) approved the first drug for which the primary efficacy data in pivotal Phase III trials was collected using an electronic diary. Allergan Inc. received the approval for its pharmaceutical ACULAR LS™ (ketorolac tromethamine ophthalmic solution), an ophthalmic non-steroidal anti-inflammatory drug.

invivodata’s ePRO system was used to capture real-time data both immediately after corneal refractive surgery and for several days afterward. Patients were asked to make repeated real-time entries on DiaryPRO, which delivered more than 7,200 reports to help distinguish them results of the drug versus a placebo. “As primary endpoint data for this drug, it was critical that submitted data were collected using a proven methodology that would meed FDA 21 CFR part 11 requirements. This approval validates our confidence in the self-report data collected with the invivodata eDiary system,” said Elizabeth Bancroft, senior director of regulatory affairs at Allergan.

Amylin Pharmaceuticals – Collection of Important Safety Data

invivodata’s DiaryPRO system delivered the critical safety and efficacy data in Amylin’s study of SYMLIN® (pramlintideacetate), which received NDA approval in March 2005.

DiaryPRO was used in the Amylin trial that was conducted to provide necessary safety information for its new drug application (NDA) amendment. The primary objective for the SYMLIN dose-titration trial was safety in the context of efficacy. invivodata’s DiaryPRO system was used to capture real-time data from subjects with Type 1 diabetes on safety and blood glucose endpoints during the trial.

The dose-titration study included 296 subjects with Type 1 diabetes who were intensively managing their disease with either multiple daily insulin injections or insulin pump therapy. Subjects used invivodata’s DiaryPRO to record real-time data about their blood glucose concentrations before and after meals, insulin use, study medication and episodes of hypoglycemia. invivodata’s patent-pending ePRO system helped subjects to comply with the demanding trial protocol, which required them to make at least five real-time diary entries per day for seven months.

Cypress BioScience / Forest Laboratories – Comprehensive Data Collection Supports Primary Endpoint in Unique Clinical Program

invivodata’s DiaryPRO was used in the pivotal clinical trials that supported the FDA’s approval of Savella® (milnacipran) for the treatment of fibromyalgia. Savella is the product of a unique clinical development program, one that considered a patient to be a responder to therapy only if they demonstrated concurrent clinically significant changes in multiple aspects of fibromyalgia. Savella is the only product approved for the management of fibromyalgia that used this composite responder analysis as its primary endpoint.

During two US pivotal Phase III clinical trials, over 2,000 patients with fibromyalgia used DiaryPRO daily to assess various aspects of their fibromyalgia, including pain (via visual analog scale), patient global assessment (via patient global impression of change) and physical function (via Short Form-36 Physical Component Summary). By capturing these important data at scheduled and random times throughout the day, DiaryPRO was able to provide comprehensive data that supported the trials’ primary endpoint and established the safety and efficacy of Savella.

Sucampo, Inc. – Industry’s First FDA Approval including Site-based ePRO Data

The U.S. FDA approved the first drug for which the primary efficacy data in pivotal Phase III trials was collected using a site-based ePRO data capture method. invivodata’s combination DiaryPRO® / SitePRO® solution captured primary efficacy data that supported the U.S. FDA supplemental approval of AMITIZA® (lubiprostone) 8 mcg twice daily for the treatment of irritable bowel syndrome with constipation (IBS-C) in women 18 years of age and older.

Throughout the Phase 2 and 3 trials, investigative site personnel used SitePRO, invivodata’s 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.

“invivodata’s 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,” said Dr. Gayle Dolecek, senior vice president of Research & Development at Sucampo Pharmaceuticals.

Alcon, Inc. – Collection of Primary Efficacy Data

invivodata’s DiaryPRO®, captured some of the primary efficacy data that supported the U.S FDA’s approval of PATANASE® (Olopatadine Hydrochloride) Nasal Spray, indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older.

For Alcon’s Phase III program, invivodata designed and implemented an eDiary solution that complied with the FDA’s guidance on the use of patient reported outcomes (PROs) in clinical research. During a two-week trial, subjects with seasonal allergic rhinitis used DiaryPRO twice daily to record the frequency and severity of their nasal symptoms. The data captured on DiaryPRO helped Alcon demonstrate a significantly greater decrease in allergy symptoms among patients using PATANASE compared with patients using a placebo nasal spray.

“We needed an efficient and specific data collection method that was easy for patients and investigative site personnel to use,” said G. Michael Wall, Ph.D., senior director, Pharmaceutical Product Development at Alcon. “invivodata met our tight enrollment timelines and delivered the scientific expertise and technology that were important to the success of this program.”

Speak to someone today about regulatory approvals using invivodata’s DiaryPRO system.