Hisamitsu Pharma filed a citizens petition at FDA on 31 December 2009 [received 1/6/10] to remind the FDA to protect its investment in the first and only FDA-approved topical pain relieving patch, Salonpas.  Over the last year Hisamitsu, the maker of Salonpas topical pain patches, has quietly charted the direction of pain relieving topical patches in the United States while others have been less than proactive.

 Find out how & why ...

We have reported on the turmoil within the topical patch category for nearly one year as patent infringement litigation and a regulatory monograph closing have threatened the price of doing business.  Yet in the face of this turmoil Hisamitsu, an ex-US manufacturer and not the US category leader, has waged a rational and persistent effort to accept, then leverage, regulatory barriers to its advantage.  While Hisamitsu remained outside of the patent infringement actions they submitted the first-to-be-approved NDA for an OTC topical pain relieving patch in February 2006, and again in July, 2007, while others were content to sit on their hands as the clock ticked.  FDA approved its application for use by adults on February 20, 2008.  As the FDA's External Analgesic Monograph heads for finality in late 2010 other manufacturers are presumably busy scrambling with IND testing in support of NDA filings for current products.

Recall in July 2003 the FDA had challenged manufacturers to "show cause" as to why topical patch forms should be subsumed in the final monograph.  It now appears that Hisamitsu approached FDA as early as 2001.  This now suggests that their proactivity may have led to FDA questioning the inclusion of patches in the monograph in 2003.  Hisamitsu, as the bellwether working with the agency, has chartered the ground rules that later applicants now have to follow.

Now this recent filing by Hisamitsu reminds FDA that it should require generics to do what it had to do:  1) clinical efficacy trials; 2) skin safety studies; 3) bioavailability trials for safety; and at the same time 4) insure identity of product design.  By filing a citizen's petition on December 31, 2009 Hisamitsu smartly secures several tactical advantages.  First, they reinforce to the FDA, and to all on-lookers, the approval hurdles they must now clear to gain market entry.  This insures that the playing field is level for store brand competition aimed directly at Salonpas.  Second, they have reminded FDA that all other branded competitors, such as BenGay (J&J), Icy Hot (Chattem/Sanofi), Wellpatch (Rohto/Mentholatum) et al need to meet a similar burden of proof.  Lastly, they remind generic store brands that each time they follow a new formula into the market they will need to invest heavily in an NDA.  Clearly store brands will need to assess the probability they can gain approval and the profitability of doing so.   Store brands may choose to exit the patch business as soon as "free" market access is shut off.

As we predicted in earlier stories the net effect of excluding topical patches from sale under the monograph will be to make it uncertain whether:  1) any existing patch product will gain approval; 2) any store brand will invest in NDA approval; and, 3) any novel, non-patch alternative forms [eg- wraps, tapes, sleeves] will keep or gain approval.  Keep in mind that IND/NDA's will need to filed for each different formula, combination, or perhaps form.  The net effect will be to circumscribe a smaller future category within which there will be fewer branded, and even fewer unbranded, product formulae, forms, and offerings.  Innovation will depend on the occasional big new idea that is patented and NDA'ed, and perhaps will arrive via switched or licensed prescription technology.  Lack of competitors, higher entry barriers, technology licensing fees, and Asian manufacturing mark up's in a non-pegged, weak dollar environment may pressure pricing in the future.

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[Dr. Riker is a former Associate Director, Personal Healthcare at Procter & Gamble, and the last Vice President of R&D & Chief Scientific Officer at Chattem]