Oral strip ondansetron held up at FDA
pharmafile | February 11, 2010 | News story | Manufacturing and Production, Research and Development |Â Â Strativa, chemotherapy, film strips, nauseaÂ
A novel formulation of ondansetron has seen its marketing application delayed at the US Food and Drug Administration (FDA) because the agency has been unable to carry out an inspection of overseas sites involved in testing and developing the product.
Zuplenz, an oral soluble film formulation of ondansetron developed by Strativa Pharmaceuticals, is the first product to come out of a collaboration between Strativa, the branded product subsidiary of generic drugmaker Par Pharmaceuticals, and drug delivery company MonoSol Rx.
Strativa says the delay is not due to any problems with the product itself. A complete response letter issued by the FDA on 5 February indicated that it was unable to perform an inspection of the clinical and analytical sites for a bioequivalence study “due to an agency-wide restriction on foreign travel in India”.
The company said it would work with the FDA to complete the inspections of the sites and finalise product labelling, while the FDA said it would try to perform an inspection as soon as possible.
Oral soluble film strips dissolve quickly in the mouth with no need to swallow a pill or take with water, and are intended for patients who have difficulty taking current oral formulations such as tablets and capsules.
Strativa is developing Zuplenz for the prevention of nausea and vomiting associated with chemotherapy, radiotherapy and surgery, and said late last year that it was expecting sales to reach around $70 million a year within four to five years of launch.
The product has been developed in two versions, 4mg and 8mg, with its marketing application based on three pharmacokinetic studies showing that it is bioequivalent with GlaxoSmithkline’s Zofran ODT brand. The orodispersible tablet formulation was formerly a blockbuster for the big pharma company, but since losing patent protection now makes sales of under $100 million a year.
Earlier this year Strativa and Monosol Rx extended their collaboration to include three additional unidentified oral soluble film products.
The first active pharmaceutical ingredient to reach the market in an oral soluble film formulation was the local anaesthetic benzocaine in a product developed by Zengen (now Migami) for the relief of sore throat.
Since then, additional over-the-counter medicines in oral strip formulations have been introduced by companies such as Johnson & Johnson (e.g. Benadryl Allergy, Sudafed PE) and Novartis Consumer Health (TheraFlu, Triaminic), but Zuplenz will be among the first prescription medicines to reach the market in this format.
Related Content
European Commission approves combination chemotherapy for treatment of advanced EGFR-mutated non-small cell lung cancer in adult patients
Today, Janssen-Cilag International, part of Johnson & Johnson (J&J) has announced that the European Comission …
AstraZeneca’s Tagrisso approved in Japan for lung cancer treatment
AstraZeneca has announced that Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy has been …
AstraZeneca’s Imfinzi approved in US for endometrial cancer treatment
AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Imfinzi (durvalumab) …
