Cornerstone Therapeutics Inc., a specialty pharmaceutical company has received the US Food and Drug Administration (FDA) acceptance for its New Drug Application (NDA) candidate, CRTX 080, product candidate for the treatment of hyponatremia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 29.

“This event marks another critical milestone in the focused execution of our strategic plan,” said Craig A Collard, Cornerstone's chief executive officer. “CRTX 080 is an important addition to our hospital product portfolio. The hyponatremia market increased 86 per cent in 2011, and we look forward to launching CRTX 080 into this rapidly expanding market.”

Hyponatremia affects up to six million people in the US with direct medical costs estimated to range between $1.6 and $3.6 billion annually. CRTX 080 is a highly potent, non-peptide, oral capsule that works by reducing the action of a hormone (vasopressin) that blocks fluid excretion. CRTX 080 acts specifically on the vasopressin-2 receptor in the kidneys, causing water to be excreted while sparing sodium without affecting other electrolytes.

“We are pleased that CRTX 080 has passed this critical threshold in the drug development cycle,” said Alan Roberts, Cornerstone's vice president, Scientific Affairs. “The FDA's acceptance of our NDA brings Cornerstone one step closer to being able to provide an effective, well-studied treatment option for this complex condition that affects millions of patients.”

Hyponatremia is a metabolic condition that occurs when there is not enough sodium (salt) in the blood. It is the most common electrolyte disorder among hospitalized patients affecting up to six million people in the US and is often diagnosed in patients with heart failure. In the US alone, there are five million heart failure patients, and each year one-fourth of them develop hyponatremia. Other causes of hyponatremia include burns, diuretic medications, kidney disease, liver cirrhosis and syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Cornerstone Therapeutics Inc. is focused on commercializing products for the hospital, niche respiratory and related specialty markets.