Pfizer to continue development of pain therapy Remoxy

Pfizer has announced that it will be proceeding with new clinical studies of its pain therapy Remoxy, as it seeks to secure US regulatory approval for the product.

Having successfully achieved several technical milestones related to manufacturing, Pfizer will be undertaking the additional studies and other actions required to address the complete response letter received from the US Food and Drug Administration in June 2011.

These include a pivotal bioequivalence study with its modified Remoxy formulation – thus creating a bridge to the clinical data related to the original Remoxy formulation – and an abuse-potential study with the modified drug.

Remoxy is an investigational extended-release oral formulation of oxycodone for the management of moderate-to-severe pain, in cases where a continuous around-the-clock opioid analgesic is needed for an extended period of time.

Acquired by Pfizer following its takeover of King Pharmaceuticals in 2011, a complete response submission for the drug is not expected to occur prior to mid-2015.

This comes after the firm was granted European approval for a new update to the label of its pneumococcal conjugate vaccine Prevenar 13 earlier this month.