UK-based Infirst Healthcare has reported positive top-line data from its Phase III IFH-2014-002 FLARE study of BC1054 to treat knee pain.
BC1054 is an orally administered soft capsule containing 200mg of lipid formulated ibuprofen used for rheumatic or muscular pain and pain of non-serious arthritic conditions to help relieve pain and swelling, as well as ease stiffness of the joints.
It is formulated in a lipid excipient matrix based on Infirst's portfolio of patented technologies.
The three-arm, double-blind, randomised, multicentre FLARE study tested the BC1054 soft gel capsule of Ibuprofen lipid formulation against the standard soft gel Ibuprofen capsule to treat patients with episodic knee arthralgia / flaring knee pain.
The study was primarily focused on determining whether the lipid formulated ibuprofen capsule administered for five days is non-inferior to standard soft gel ibuprofen capsules, to be determined through the basis of pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Results suggested that the study achieved its primary objective of asserting the efficacy of low dose lipid formulated ibuprofen capsule, to that of high and low doses of standard soft gel ibuprofen capsules.
Infirst drug development head Karen Stoner said: "Continuing the development of safer and more effective anti-inflammatory treatments is an important goal for drug development.
"Infirst Healthcare believes that more effective treatments can be found by taking a closer look at existing medicines, and lipid formulated ibuprofen is an excellent example of this.
“By maximising efficacy at the lowest dose and for the shortest duration of treatment, we aim to improve the benefit-risk profile for patients.
"Low-dose (1200mg daily dose) lipid formulated ibuprofen will provide an important new treatment option for patients and healthcare professionals.
“We are pleased with the positive outcome for our lipid formulated ibuprofen in this Phase III trial."