NexMed, Inc, a specialty CRO and a developer of products based on the NexACT technology, has received delivery confirmation for its response to the CMC (Chemistry, Manufacturing and Controls) concerns raised by Health Canada (Response). The response is part of the review process for its New Drug Submission (NDS) for Vitaros, the company's topical treatment for erectile dysfunction treatment, which was filed in February 2008. Health Canada has a 45-day screening for acceptance process of the Response by their Regulatory Project Management group. The acceptance of the Response triggers a new, 150-day review cycle by the NDS reviewers for a final approval or rejection of the marketing application.
On January 19, 2010, NexMed announced that it had received a Notice of Non-Compliance (Notice) for its NDS pertaining to the review by the New Drugs Quality Division of the Bureau of Pharmaceutical Sciences. The Notice is a routine, end-of-review communication from Health Canada issued when additional information is required to reach final decision on product approval
Dr Bassam Damaj, president and chief executive officer of NexMed, stated, "NexMed met with Health Canada officials in February 2010 to discuss the deficiencies cited in their Notice. At that time, we were given guidance and reached agreement with the regulatory officials on the additional information to be included in our Response, which we then submitted in a timely manner. We look forward to receiving Health Canada's decision and continue to be positive about the possibility of eventual product approval."
NexMed is the largest specialty CRO based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models.