- Safety & Recalls
- Regulatory Updates
- Drug Coverage
- COPD
- Cardiovascular
- Obstetrics-Gynecology & Women's Health
- Ophthalmology
- Clinical Pharmacology
- Pediatrics
- Urology
- Pharmacy
- Idiopathic Pulmonary Fibrosis
- Diabetes and Endocrinology
- Allergy, Immunology, and ENT
- Musculoskeletal/Rheumatology
- Respiratory
- Psychiatry and Behavioral Health
- Dermatology
- Oncology
New diet drug overwhelmingly endorsed by FDA committee
A new weight-loss medication got an overwhelming endorsement on Wednesday from FDA?s Endocrinologic and Metabolic Drugs Advisory Committee. The committee voted 20-2 in favor of approving phentermine/topiramate (Qnexa, Vivus).
A new weight-loss medication got an overwhelming endorsement on Wednesday from FDA’s Endocrinologic and Metabolic Drugs Advisory Committee. The committee voted 20-2 in favor of approving phentermine/topiramate (Qnexa, Vivus).
Vivus submitted data showing median weight loss exceeding 10% during the first 2 years of use. Data also showed significant improvement in cardiovascular, glycemic, metabolic, and inflammatory end points.
If FDA follows its advisory committee lead, phentermine/topiramate would be the first weight loss drug to be approved since orlistat (Xenical, Genentech) came to market in 1999. If approved, the drug would be indicated for patients with a body mass index of 27 or greater with weight-related comorbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity. The agency is expected to issue its decision by April 17.
FDA rejected phentermine/topiramate in 2010 over concerns about increased rates of cleft lip and cleft palate birth defects and increased heart rate. The agency could require Vivus to conduct large-scale, post-marketing studies as part of its approval. More than 35% of US adults are obese and another third are overweight.
“Of all the obesity drugs, this one has the highest efficacy in terms of weight loss, so that shifts the balance in terms of requiring a post-approval study rather than a pre-approval study,” said panel member Sanjay Kaul, MD, MPH, professor of medicine at the Geffen School of Medicine at the University of California Los Angeles.
Vivus has proposed a major trial following 11,300 patients over 4.5 years to assess the effect of phentermine/topiramate on reducing major cardiovascular events in at-risk obese patients. Analysts estimate sales of $448 million in 2015 if the drug is approved.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
