Penwest drops drug development
Penwest Pharmaceuticals has been issued a non-approvable letter for the its New Drug Application (NDA) for PW2101, a beta blocker intended for the treatment of hypertension and angina, by the US FDA.
Penwest Pharmaceuticals has been issued a non-approvable letter for the its New Drug Application (NDA) for PW2101, a beta blocker intended for the treatment of hypertension and angina, by the US FDA.
The FDA stated that the NDA was non-approvable due to, among other things, the degree of kinetic variability of PW2101 observed among individuals and because beta blockade as a surrogate for efficacy was not demonstrated across the entire interdosing interval on an individual subject basis.
Given the FDA's concerns and the time and resources Penwest expects it would take to address them, as well as the commercial window for the product opportunity, the company has decided not to undertake the additional activities that it believes would be required to address the FDA's concerns.
Robert J. Hennessey, president and ceo, said: 'we are very disappointed by the FDA's decision. We are continuing the development of the other product opportunities in our portfolio and are pleased with the progress we are making in developing compounds targeted at diseases of the central nervous system.'
The company specialises in pharmaceutical products based on innovative oral drug delivery technologies.