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FDA approves roflumilast for severe COPD
FDA approved the first-and-only selective phosphodiesterase type 4 inhibitor roflumilast (Daliresp, Forest Pharmaceuticals), once-daily oral tablet to decrease the frequency of exacerbations or worsening of symptoms from severe chronic obstructive pulmonary disease.
FDA approved the first-and-only selective phosphodiesterase type 4 (PDE-4) inhibitor roflumilast (Daliresp, Forest Pharmaceuticals), once-daily oral tablet to decrease the frequency of exacerbations or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).
It is indicated for people with severe COPD to treat the symptoms of cough and excess mucus linked to bronchitis. Roflumilast is not intended to treat another form of COPD that involves primary emphysema.
Last April, FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 10 to 5 that safety and efficacy data were not strong enough to approve the drug as maintenance treatment for COPD patients with chronic bronchitis who are at risk of exacerbations, MedPage Today reported. Among patients taking roflumilast in clinical trials, 14% discontinued the drug because of side effects that included weight loss, psychiatric events including suicide, and the potential for cancer.
“The FDA Advisory committee was not favorable to this drug last year so its approval by FDA creates somewhat of a quandary as to the true medical usefulness of this product, let alone potential safety concerns,” Randy Vogenberg, PhD, principal at the Institute for Integrated Healthcare in Sharon, Mass., and executive director of the Biologic Access & Finance program at The Jefferson School of Population Health in Philadelphia, told Formulary.
“Newer biologic products such as this will offer a mixed value proposition to health plan sponsors making it difficult to predict a marketing slam dunk for such products,” Vogenberg said.
The safety and effectiveness of roflumilast was demonstrated in 2 phase 3 clinical studies that included more than 1,500 patients aged 40 years and older who received roflumilast. Those treated had a history of COPD associated with chronic bronchitis and had experienced an exacerbation of the disease during the 12 months prior to beginning treatment.
FDA approved roflumilast with a medication guide informing patients of the potential risks of mental health problems, including changes in mood, thinking, or behavior, as well as unexplained weight loss.
Roflumilast should not be used to treat sudden breathing problems (acute bronchospam), and is not recommended for people younger than 18 years. The most common side effects reported by those receiving roflumilast included diarrhea, nausea, headache, insomnia, back pain, decreased appetite, and dizziness.
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.
