CENTRA PLANNING 1994 FAMOTIDINE SWITCH

Centra Healthcare expects to receive approval to make its histamine H2 antagonist famotidine available for over-the-counter use in the UK by early 1994, according to company representatives speaking at a press conference in London. The initial indications sought will be short-term relief of heartburn, dyspepsia and hyperacidity, with a maximum treatment period of two weeks.

The amendment to the Prescription-Only Medicine order necessary for OTC sale is expected to be laid before the UK parliament by the end of this month. If the switch is approved, famotidine will be made available in a 10mg tablet formulation, with a maximum daily dose of 20mg, said Centra. The company has carried out two placebo-controlled trials, involving a total of over 500 patients, which clearly show that famotidine relieves heartburn effectively with a low incidence of adverse effects.

SmithKline Beecham says it is also aiming for an OTC approval for its cimetidine product in early 1994 in the UK, while Glaxo's Zantac (ranitidine), the best-selling drug in this class (and indeed the world), is not expected to be available for OTC use until mid-1995. SB recently had a setback in its switch efforts for cimetidine when a US Food and Drug Administration advisory committee declined to recommend its product, saying that it was not convinced by the efficacy data presented by the company (Marketletter September 20).