Cornerstone BioPharma Announces FDA Approval of Balacet 325
Drug News-- June 20, 2005
Cornerstone BioPharma Announces FDA Approval of Balacet 325
Balacet 325 was approved for the Treatment of Mild to Moderate Pain
in Patients 18 years of age and older
CARY, N.C., June 20, 2005 -- Cornerstone BioPharma, Inc. the Triangle-based specialty pharmaceutical company currently focused on the development and commercialization of niche prescription medications in the pain, anti-infective, and respiratory markets, announced that Balacet 325 (100 mg propoxyphene napsylate and 325 mg acetaminophen) Tablets (CIV) was approved by the Food and Drug Administration (FDA) for the treatment of mild to moderate pain in patients 18 years of age and older.
Balacet 325 attacks mild to moderate pain while helping to reduce the risk of acetaminophen toxicity. At the maximum daily dose, Balacet 325 contains 1950 mg of acetaminophen, which is half of US Pharmacopeia's recommended maximum daily limit of 4000 mg for short-term use (less than or equal to 10 days). The recommended daily limit for long-term use (greater than 10 days) is 2600 mg.
"A recent study showed that less than a third of patients know that too much acetaminophen can cause liver damage. Balacet 325 was developed to help ameliorate the pain patients are feeling while reducing the risk of acetaminophen toxicity," said Craig Collard, CEO of Cornerstone BioPharma.
"Only the patient knows their pain. Physicians listen to the patients description of pain to determine the kind of pain they are experiencing, and thus prescribe the best medication with the lowest risk of side effects," said Hayes Wilson, MD, Director of Rheumatology at Piedmont Hospital, Atlanta, GA. "Balacet 325 is a more patient friendly formula of propoxyphene and acetaminophen - an old friend to the medical community. I feel Balacet 325 will effectively treat mild to moderate pain while lowering the risk of acetaminophen toxicity."
Acute pain is generally caused by injury or surgery, and is the most common reason that 25 million patients seek medical attention in the US annually. In addition to unnecessary suffering, inadequately controlled acute pain can lead to chronic pain and cause complications that can increase the length of hospital stays, re-hospitalization rates, and outpatient visits.
Balacet 325 is now available in retail pharmacies.
Source: Cornerstone BioPharma, Inc.
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