OmniComm Systems Signs Multi-Million Dollar, 5-Year Agreement

OmniComm Systems, Inc. recently announced that one of the top five medical research universities in the US, selected OmniComm TrialMaster EDC and related services to conduct a series of clinical studies over a 5-year period.

OmniComm TrialMaster EDC was selected from a broad field of competitors for its inherent flexibility, scalability, data quality, and broad capabilities. Realizing the benefits of eSource is an important initiative for this academic research center. OmniComm’s expertise and know-how integrating electronic medical record (EMR) systems with TrialMaster EDC was an important factor in the decision.

TrialMaster EDC will integrate with their EMR system, enabling a comprehensive eSource solution. Data captured from the EMR will be automatically imported into the clinical study in TrialMaster, speeding the process of data capture and reducing errors. OmniComm will use the Retrieve Form for Data-capture (RFD) integration profile that was co-developed by CDISC and Integrating the Healthcare Enterprise (IHE), a healthcare interoperability enabler.

“We are proud to partner with one of the nation’s leading academic medical research institutes, providing the most advanced EDC and eSource technology to accelerate their medical research efforts,” said Kuno van der Post, SVP of business development, OmniComm. “TrialMaster EDC is built-for-purpose to run the full array of clinical studies, regardless of complexity, at scale, and with the highest level of performance. TrialMaster EDC was deemed to be the best fit for this challenging environment from a broad selection of systems.”

OmniComm Systems, Inc. is a leading strategic software solutions provider to the life sciences industry. OmniComm is dedicated to helping the world’s pharmaceutical, biotechnology, contract research organizations, diagnostic and device firms, and academic medical centers maximize the value of their clinical research investments. Through the use of innovative and progressive technologies, these organizations drive efficiency in clinical development, better manage their risks, ensure regulatory compliance, and manage their clinical operations performance. OmniComm provides comprehensive solutions for clinical research with an extensive global experience from over 4,000 clinical trials. For more information, visit www.omnicomm.com.

Egalet Announces FDA Advisory Committees Recommend Approval of Abuse-Deterrent ARYMO ER

Egalet Corporation recently announced that the joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US FDA voted 18 to 1 to recommend approval of ARYMO ER (morphine sulfate). ARYMO ER was developed using Egalet’s proprietary Guardian Technology for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The committees also voted:

• 16 to 3 that if approved, ARYMO ER should be labeled as an abuse-deterrent product by the oral route of abuse;
• 18 to 1 that if approved, ARYMO ER should be labeled as an abuse-deterrent product by the nasal route of abuse; and
• 18 to 1 that if approved, ARYMO ER should be labeled as an abuse-deterrent product by the intravenous route of abuse.

“The Committees’ support of ARYMO ER labeling as an abuse-deterrent product by the intravenous, nasal, and oral routes of abuse is an important step forward in the development of this product candidate,” said Bob Radie, President and CEO of Egalet. “We believe ARYMO can offer patients, when appropriate, effective pain relief and can deter potential abuse. We will continue to work closely with the FDA over the next few months to bring this product to the market.”

Based on the committees’ votes, Egalet anticipates, if approved, the label for ARYMO ER will describe the product’s abuse-deterrent properties that are expected to reduce, but not totally prevent, abuse of the drug when the tablets are manipulated. The FDA is not bound by the recommendations of its advisory committees, but will consider their guidance during the review of the NDA for ARYMO ER. The FDA Prescription Drug User Fee Act (PDUFA) goal date for a decision is October 14, 2016.

Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing, and commercializing innovative treatments for pain and other conditions. Egalet has two approved products: OXAYDO® (oxycodone HCI, USP) tablets for oral use only CII and SPRIX® (ketorolac tromethamine) Nasal Spray. In addition, using its proprietary Guardian Technology, Egalet is developing a pipeline of clinical-stage, product candidates that are specifically designed to deter abuse by physical and chemical manipulation. The lead programs, ARYMO ER, an abuse-deterrent, extended-release, oral morphine formulation, and Egalet-002, an abuse-deterrent, extended-release, oral oxycodone formulation, are being developed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.