NASHVILLE, TN--(Marketwired - Apr 7, 2015) - Lori Nesbitt, PharmD, Chief Executive Officer of Compass Point Research, announced today that the company has entered into an agreement with NDA Partners LLC, a highly regarded medical product development and regulatory strategy consultancy, to collaborate in the development of a new combination drug for the treatment of migraine headaches. Compass Point has been retained by the drug sponsor, MultiCorp International, Inc., a publicly traded company located in Sun Valley, CA, to manage the product development program, and NDA Partners will provide the drug development and regulatory expertise needed to prepare a development plan for a 505(b)(2) NDA submission to the US Food & Drug Administration (FDA) and to manage a preIND meeting with the FDA review division.
The product is a combination of two currently FDA approved drugs, diphenhydramine (Benadryl®) and trimethobenzamide (Tebamide®, Tigan®), both of which can be delivered in an oral dosage form. Diphenhydramine is used clinically in combination with other dopamine antagonists such as prochloperazine and metoclopramide as first line therapy to treat migraine headaches. Trimethobenzamide is an antiemetic used to prevent nausea and vomiting. In an emergency department-based clinical study conducted in 2005, the drug combination, delivered as a single injection intramuscularly, demonstrated pain relief, tolerability, and efficacy at 24 hours compared to subcutaneous sumatriptan.
NDA Partners has assembled a highly experienced product development team with comprehensive expertise that includes regulatory strategy, nonclinical development, toxicology, CMC, clinical pharmacology, and experience in demonstration of clinical effectiveness of new migraine treatments. The team will be led by Charles Grudzinskas, PhD, a Partner in the firm who has led efforts to develop and register dozens of new medical products, and includes David Feigal, MD, former Director, FDA Center for Devices & Radiological Health (CDRH); Jeanine Kuczik, a Partner in NDA Partners with significant experience in the development of migraine treatments; and Anthony DiSanto, PhD, former Vice President of Worldwide Drug Delivery Research & Development for the Upjohn Company.
"We are very pleased to be able to combine our extensive drug development and operational experience with world class development and regulatory experts from NDA Partners," said Dr. Nesbitt. "Together, we will deliver an outstanding solution for our client."
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include two former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of approximately 60 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.
MultiCorp International, Inc. (Sun Valley, CA) is a diversified company that operates in various business sectors including property development, constructions, medical, and hospitality as well as commodities such as oil and gas, and entertainment. The vision of management for the company is to diversify into many fields wherein management's expertise, along with its strategic partner's experience, will enable it to participate in high growth markets and increase profitability.
"This is an important program for us, and we believe we have a potential break-through product under development that can provide longer-lasting relief for those suffering from migraine headaches," said Ben Friedman, Rph and President of MultiCorp International, Inc. "Compass Point has assembled an outstanding team to help us develop this product, and we look forward to working with them to fill this important medical need."
About Compass Point Research
Compass Point Research is a full-service clinical and translational research management and consulting firm. The company's focus is on facilitating all aspects of clinical trials operations for community-based healthcare providers, including drug, device, nutritional supplement and consumer product development from discovery through clinical studies, and post-approval support. In addition, Compass Point develops and coordinates multi-center outcomes and registry trials for industry sponsors, healthcare providers and payers, delivering scientifically rigorous research outcomes in an affordable environment. The company has been able to assist providers with not only eliminating a subsidy for research, but actually realizing a net profit for the department or cost center while adhering to all governing regulations and internal standard operating procedures.