GSK’s epilepsy treatment Potiga wins US approval
pharmafile | June 13, 2011 | News story | Sales and Marketing | GSK, Potiga, Trobalt, Valeant, epilepsy
The FDA has approved GlaxoSmithKline and Valeant’s epilepsy treatment Potiga, but the drug will require further review before it can be launched.
Potiga (ezogabine), known as Trobalt (retigabine) outside the US, has been approved as an adjunctive treatment of partial-onset seizures in adult patients.
The FDA has recommended that Potiga be reviewed as a controlled substance under the Controlled Substances Act, and GSK and Valeant can not launch it until this process is complete.
The Drug Enforcement Agency (DEA) review Potiga to assess its potential to be abused as a narcotic – a process that could see the Agency issue a control order against the use of the drug.
Potiga also has a number of serious side effects, and the FDA has issued a Risk Evaluation and Mitigation Strategy for the drug because of the possibility of urinary retention and the symptoms of acute urinary retention.
In clinical trials Potiga caused urinary retention in a number of patients, and 29 out of 1,365 – around 2% – reported the problem as an adverse event.
But despite these issues, both GSK and Valeant said they hope Potiga will be available for launch in the US by the end of the year.
Valeant has forecast optimistic peak sales of up to $1.5 billion for the drug, but analysts have been more cautious, estimating anything from $200 million to $800 million a year.
Susan Hall, head of R&D at Valeant, said: “We are so pleased to reach such an important milestone with the US approval of Potiga by the FDA.
“We believe this product will play a needed role in the management of partial onset seizures in appropriate patients who are uncontrolled on their current medications.”
The drug will represent new competition for existing epilepsy drugs such as Pfizer’s Lyrica and UCB’s Keppra.
Analysts say the new drug’s unique mechanism of action will help it establish itself in the therapy area, where older off-patent drugs such as GSK’s own Lamictal, J&J’s Topamax and Pfizer’s Neurotin are widely used.
In Europe Trobalt was approved in March this year as an adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy.
Ben Adams
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