Welcome To The Nuvo Research HUB On AGORACOM

Pennsaid will take the pain away!

Free
Message: NUVO RESEARCH ANNOUNCES SUCCESSFUL COMPLETION OF ALL PENNSAID® STUDIES

NUVO RESEARCH ANNOUNCES SUCCESSFUL COMPLETION OF ALL PENNSAID® STUDIES

posted on Jan 28, 2009 04:57AM

NUVO RESEARCH ANNOUNCES SUCCESSFUL COMPLETION OF ALL PENNSAID

®

STUDIES

-Expects to File Pennsaid FDA Resubmission Within 60 Days-

Mississauga, Ontario, Canada – January 28, 2009 - Nuvo Research Inc. (TSX: NRI),

a

Canadian drug development company focused on the research and development of drug products

delivered to and through the skin using its topical and transdermal drug delivery technologies, today

announced that it has successfully completed all of the studies that will support the Company’s

resubmission of its Pennsaid application to the United States Food and Drug Administration (FDA).

Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), is currently marketed in Canada

and several European countries to treat the pain and symptoms associated with osteoarthritis.

“We are confident that the results and information gathered from these studies will provide the FDA

with the data it requires to give Nuvo final, unconditional approval to market Pennsaid in the U.S.”

said Dr. Henrich Guntermann, President and CEO of Nuvo.

Nuvo is in the process of finalizing its resubmission for Pennsaid approval, which it expects to file

with the FDA within the next 60 days. Upon acceptance of the filing, the FDA is expected to provide

Nuvo with a date under the Prescription Drug User Fee Act (the PDUFA date), by which the FDA

will advise Nuvo of its decision respecting Pennsaid’s approvability. Nuvo anticipates the PDUFA

date will be six months after it files its Pennsaid resubmission.

Nuvo’s resubmission is a complete response amendment to an approvable letter for Pennsaid

received from the FDA in December of 2006. In that letter, the FDA confirmed that Pennsaid could

be approved for sale in the U.S. once certain conditions were satisfied. None of the conditions

relate to clinical efficacy or clinical safety of Pennsaid, which were evidenced in Nuvo’s Phase 3

clinical trials, and the FDA has not requested that Nuvo conduct any additional clinical efficacy or

safety trials.

The conditions in the approvable letter relate to the proposed Pennsaid bottle, the potential

interaction of Pennsaid with other topical products and the requirement that Nuvo conduct preclinical

studies to support the dermal safety of Pennsaid.

Nuvo believes that the completed studies, announced today, support the safety of the Pennsaid

bottle, and provide the specific information identified by the FDA as needed to support the safe use

of Pennsaid with other topical products. In addition, and as requested by the FDA, Nuvo has

completed two pre-clinical repeat dose dermal toxicology studies in animals (the “Dermal Tox

Studies”), both of which support Pennsaid’s safety.

The FDA previously confirmed in written meeting minutes that a two-year dermal carcinogenicity

study in animals (the “Dermal Carcinogenicity Study”) could be completed and submitted to the

FDA post approval provided that the Dermal Tox Studies did not show signals of safety concern.

Nuvo believes that there are no such signals in the Dermal Tox Studies and intends to complete

and submit the Dermal Carcinogenicity Study post approval as per its agreement with the FDA.

About Pennsaid

Pennsaid is a topical non-steroidal anti-inflammatory drug used for the treatment of osteoarthritis.

Pennsaid allows the active ingredient, diclofenac, to be delivered to a specific site via the surface of

the skin and thus limits complications associated with systemic delivery. According to published

Share
New Message
Please login to post a reply