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Pipeline Preview
Recent FDA action (through July 2012) related to, morphine and oxycodone Dual Opioid platform, MoxDuo, QRxPharma, apixaban, Eliquis, Bristol-Myers Squibb, RG1068, Repligen, Multi-Stem, Athersys, Rivaroxaban, Xarelto, Janssen, Ocriplasmin intravitreal injection, ThromboGenics, Regorafenib, Bayer, Onyx Pharmaceuticals, Pregabalin, Lyrica, Lupin, Diclofenac sodium and misoprostol, Arthrotec, Watson, Next Choice One Dose, Plan B One-Step
Complete response
■ New Drug Application (NDA) for morphine and oxycodone Dual Opioid platform (MoxDuo, QRxPharma) for the treatment of moderate to severe acute pain. The company is presently considering its response to the requests for additional information with regard to the safety and effectiveness of MoxDuo and has been granted a meeting with FDA to clarify the steps required for approval.
■ A New Drug Application (NDA) for apixaban (Eliquis, Bristol-Myers Squibb) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The complete response letter (CRL) requests additional information on data management and verification from the ARISTOTLE trial. A company press release stated that Bristol-Myers Squibb and Pfizer will work closely with FDA on the appropriate next steps for the apixaban application. FDA has not requested that the companies complete any new studies. FDA and the companies are committed to working expeditiously to address the outstanding questions and move the application forward.
Orphan drug designations
■ Proprietary cell therapy (MultiStem, Athersys) for the treatment of Hurler's syndrome, also known as mucopolysaccharidosis type I or MPS-I.
Priority review
■ Rivaroxaban (Xarelto, Janssen) for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and the long-term prevention of recurrent DVT and PE.
■ Ocriplasmin intravitreal injection, 2.5 mg/mL (ThromboGenics) for the treatment of symptomatic vitreomacular adhesion including macular hole.
■ Regorafenib (Bayer and Onyx Pharmaceuticals) for the treatment of patients with metastatic colorectal cancer.
First-time generic approvals
Pregabalin capsules in 25-mg, 50-mg, 75-mg, 100-mg, 150-mg, 200-mg, 225-mg, and 300-mg strengths (equiv to Lyrica)
LUPIN
Diclofenac sodium and misoprostol delayed-release tablets (equiv to Arthrotec)
WATSON
Next Choice One Dose (levonorgestrel) tablets in 1.5-mg strength (equiv to Plan B One-Step)
WATSON
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.
