FDA rejects Valeant’s efinaconazole on packaging grounds
pharmafile | May 29, 2013 | News story | Manufacturing and Production |Â Â FDA, ValeantÂ
Valeant Pharmaceuticals has had its application to market antifungal candidate efinaconazole turned down by the FDA because of issues related to the primary packaging used in the drug.
The company said the regulator had issued a Complete Response Letter (CRL) in regard to its application to market efinaconazole for fungal nail infections (onychomycosis), which included questions about the container closure apparatus used.
“As no efficacy or safety issues were raised by the FDA, Valeant believes that these items can be addressed and is working for a timely response to the FDA as soon as possible,” said Valeant in a statement.
Efinaconazole is a triazole antifungal presented as a 10% topical cream that in trials provided improved cure rates compared to the approved nail polish (lacquer) formulations, with efficacy rivalling that seen with systemic antifungals given orally.
Currently the only approved topical treatment for onychomycosis in the US is Valeant’s own Penlac (ciclopirox), which has a cure rate of just 5.5% to 8.5% according to its labelling but still achieved sales of around $300 million a year before succumbing to generic competition.
Topical drugs are normally given before oral treatments for nail infections because they have fewer side effects, although many patients go on to require systemic therapy with drugs such as Novartis’ Lamisil (terbinafine) or Janssen’s Sporanox (itraconazole) because cure rates are fairly low.
If it is eventually approved efinaconazole is expected to make rapid inroads into the market thanks to its efficacy and safety profile, with analysts suggesting it could become a $200 million-plus product at peak.
The news comes after Valeant had already said it would delay a launch of efinaconazole until after an arbitration hearing with Anacor Pharmaceuticals, which is scheduled to take place in September.
Anacor is developing its own onychomycosis treatment – tavaborole – and is seeking $215m in a dispute involving development services for this product provided by Dow Pharmaceutical Sciences (DPS), which was acquired by Valeant in 2009.
Phil Taylor
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