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Pennsaid® Plus
The Company began exploring formulations to improve the original
Pennsaid formulation in late 2004. The Company has completed
preliminary testing of a new, improved version of Pennsaid, currently
referred to as Pennsaid Plus. While no clinical trials of this product
have taken place to date, in vitro and in vivo tests have indicated that Pennsaid Plus may increase the transport of diclofenac, the active
therapeutic drug in both original Pennsaid and Pennsaid Plus, through
the skin with less frequent dosing than Pennsaid providing Pennsaid
Plus with potential advantages over Pennsaid. The development of Pennsaid Plus is an important step in the Company's plan to develop a
family of topically applied drugs with applications in a number of
therapeutic areas.
Pennsaid Plus is not currently approved for sale or marketing in any
jurisdiction. Based on meetings with the FDA in 2008, it was determined
that two pivotal phase 3 clinical trials will be required to demonstrate the clinical efficacy of Pennsaid Plus.
Licensing partner, Covidien will assume responsibility for all future
development activities and expenses for Pennsaid Plus, including the two
phase 3 trials. Additional clinical and non-clinical studies may be required to support applications for the regulatory approval of Pennsaid
Plus in the U.S. and other jurisdictions where the Company may market
the product. There can be no assurance that such trials will be
sufficient for regulatory authorities or that studies will yield
successful results or that the required regulatory approvals will be
obtained.
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