Nuvo Research Announces FDA Has Accepted Pennsaid 2% New Drug Application for review
MISSISSAUGA, ON, /PRNewswire/ - Nuvo Research Inc. (Nuvo) (TSX:NRI), a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and the development of its immune modulating drug candidate WF10 today announced that its U.S. licensee for PENNSAID® (diclofenac sodium topical solution) 1.5% w/w and PENNSAID 2% (diclofenac sodium topical solution) 2% w/w, Mallinckrodt (NYSE: MNK) has advised that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the New Drug Application (NDA) for PENNSAID 2% submitted by Mallinckrodt on August 7, 2013. The FDA has indicated to Mallinckrodt that it expects to respond to the NDA by February 7, 2014.
On March 4, 2013, Mallinckrodt received a Complete Response Letter (CRL) from the FDA following the review of Mallinckrodt's New Drug Application for PENNSAID 2%. In the CRL, the FDA required that Mallinckrodt complete a pharmacokinetic (PK) study comparing PENNSAID 2% to original PENNSAID. Mallinckrodt completed the PK study and on August 7, 2013 submitted the clinical study report to the FDA.
About PENNSAID:
PENNSAID is a non-steroidal anti-inflammatory drug (NSAID) used for treating the signs and symptoms of osteoarthritis of the knee(s).
PENNSAID is the only FDA-approved topical NSAID for the treatment of knee osteoarthritis which demonstrated statistically significant differences in all three primary efficacy endpoints: pain and physical function (WOMAC®), patient overall health assessment (POHA), and patient global assessment of knee osteoarthritis.
PENNSAID is a registered trademark of Nuvo Research Inc.
WOMAC is a registered trademark of Nicholas Bellamy.
WOMAC® is a proprietary health status questionnaire. For further information visit the WOMAC® website at www.WOMAC.com.
About PENNSAID 2%:
PENNSAID 2% is a follow-on product to original PENNSAID which is currently marketed in the U.S. by Mallinckrodt under license from Nuvo. PENNSAID 2% is a topical non-steroidal anti-inflammatory drug (NSAID) containing 2% diclofenac sodium compared to 1.5% for original PENNSAID. It is more viscous than original PENNSAID, is supplied in a metered dose pump bottle and was studied in clinical trials using twice daily dosing compared to four times a day for original PENNSAID.
About Nuvo Research Inc.:
Nuvo is a publicly traded, Canadian specialty pharmaceutical company, headquartered in Mississauga, Ontario. The Company is building a portfolio of products for the treatment of pain through internal research and development. The Company's product portfolio includes Pennsaid®, Pliaglis and a heated lidocaine/tetracaine patch (HLT patch). Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), is used to treat the signs and symptoms of osteoarthritis of the knee(s). Pennsaid is sold in the U.S. by Mallinckrodt Inc. in Canada by Paladin Labs Inc. and in several European countries. Pliaglis is a topical local anesthetic cream which provides topical local analgesia for superficial dermatological procedures. The Company has licensed worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a global pharmaceutical company specialized in dermatology. Galderma launched the marketing and sale of Pliaglis in the U.S. in March of 2013 and in the E.U. in April of 2013. The HLT patch is a topical patch that combines lidocaine, tetracaine and heat and is approved in the U.S. to provide local dermal analgesia for superficial venous access and superficial dermatological procedures and in Europe, for surface anaesthesia of normal intact skin. Nuvo's licensing partner, Galen US Incorporated markets the HLT patch (under the name Synera) in the U.S. In Europe, Nuvo's licensing partner, Eurocept International B.V., has initiated a pan-European launch of the HLT patch (under the name Rapydan). The Company is also developing WF10, for the treatment of immune related diseases.