Approximately half, or an estimated 13.5 million, of the 27 million Americans living with osteoarthritis pain also suffer from high blood pressure. Many of these 13.5 million people cannot take the standard drugs used to treat osteoarthritis pain, nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs raise the risk of further increasing blood pressure (hypertension), and potentially causing stroke or heart attacks. In July of 2015 the FDA issued a safety warning stating the risk of heart of attack associated with NSAIDs can occur as early as the first weeks of using an NSAID and the risks may increase with longer use. This leaves prescribing doctors in a difficult spot.
Non-compliance on the part of patients is also a large challenge for the healthcare system. Two-thirds of people living with hypertension lack proper control of their blood pressure due to not taking medication as prescribed. This leads to health risks and higher costs associated with hospitalization. Hospitalization costs were $3,500 more per non-compliant hypertension patient, as compared to compliant patients.
Kitov Pharmaceuticals’ combination drug KIT-302, which treats both osteoarthritis pain and hypertension in one pill, is a solution that doctors are now considering. It is designed to be a safer drug that virtually eliminates harmful side effects. The drug has completed a successful Phase 3 trial and is slated for NDA submission in the coming months. KIT-302 is comprised of two FDA-approved drugs, celecoxib (Celebrex®) for the treatment osteoarthritis pain and amlodipine besylate (amlodipine), a drug designed to treat hypertension.
In a recent market assessment, commissioned by Kitov, a third party payor which insures millions of covered lives, stated the following regarding KIT-302, “The actual idea that pain is a stimulant for compliance in brilliant.” Most payors were intrigued by the idea that people would be motivated to take their hypertension drug because it is in one tablet with their pain drug. Osteoarthritis pain relief drugs have a higher compliance rate due to the obvious reason: pain is a motivator to take a pill.
Of the 110 Key Opinion Leaders and high volume prescribers interviewed, including general practitioners, internal medicine, pain specialists, rheumatologists and orthopedic surgeons, doctors stated they would prescribe KIT-302 to 40% of their patients currently treated with celecoxib. They also reported they would prescribe KIT-302 to 25% of their osteoarthritis patients who are not being treated with celecoxib. The physicians’ predicted prescribing behavior was based on KIT-302’s target product profile from its Phase 3 clinical data.
Following submission of its NDA, Kitov hopes to get FDA clearance to market KIT-302 by the end of 2017 or beginning of 2018. Patients and doctors will have an alternative that is safe, effective and promotes higher compliance.