The US Food and Drug Administration has asked for more data relating to Rectogesic, which is used to treat the pain associated with chronic anal fissures. The drug is already used in 34 countries.
Chief executive Dr Wilson Totten said he had not projected US revenues from Rectogesic in internal budgets. He added: "Even though this product is approved in the European Union, it was always possible further data may be required for a US approval. With this in mind, we had not committed to commercialising Rectogesic ourselves in the US."