FDA relaxes halt on Invicorp trials

The US Food and Drug Administration has upgraded the status of Senetekof the UK's injectable erectile dysfunction drug, Invicorp (vasoactive intestinal peptide plus phentolamine mesylate), to partial clinical hold, allowing human studies to be conducted in the USA provided they do not exceed three months in duration and have a limit of three doses per week.

The FDA has also recommended that Senetek conduct a two-year rodent study of the drug to investigate the previously-reported brown adipose tissue proliferations observed in the course of an animal study, conducted by competitor Zonagen, in which rodents were given a daily dose of phentolamine mesylate. Zonagen and partner Schering-Plough are developing an oral formulation of phentolamine mesylate for ED, under the trade name Vasomax, which had also been subject to a ban on clinical trials but was recently upgraded to a partial clinical hold (Marketletters passim).

Meanwhile, Senetek has been granted approval for Invicorp in New Zealand, which helped spark a 13% rise in the company's Nasdaq-listed shares. Invicorp was first approved in Denmark in 1998 and is also conditionally-approved in the UK, where it is available on a named-patient basis. The UK's Committee on Safety of Medicines is due to meet in July to review its status, and the Medicines Control Agency is expected to deliver a verdict in August, notes Senetek. The product is also being reviewed for a pan-European Union approval, using Denmark as the reference member state.