FDA approves new NSAID
The FDA has approved diclofenac (Zorvolex), a new diclofenac product indicated for the treatment of mild-to-moderate acute pain in adults. Zorvolex, a product of Iroko Pharmaceuticals, was approved at dosage strengths that are 20% lower than currently available diclofenac products. It is the first nonsteroidal anti-inflammatory drug (NSAID) developed using SoluMatrix Fine Particle Technology, which allows the reduction in diclofenac particle size, an innovation that provides an increased surface area, leading to faster dissolution.
The approval was based on data from a Phase 3 multicenter randomized study in which patients treated with Zorvolex reported significant pain relief compared with patients receiving placebo.
The risk of serious adverse events, including cardiovascular thrombotic events, myocardial infarction, stroke, gastrointestinal ulcers and bleeds, and renal events associated with NSAIDs is higher among patients receiving higher NSAID doses. Consult product labeling for further information on these risks and contraindications to Zorvolex.
The FDA finished its phase-out of all inhaler medical products containing chlorofluorocarbons (CFCs) on December 31, 2013. The agency has made this effort to comply with an international treaty to protect the ozone layer by phasing out the worldwide production of substances, including CFCs, which deplete it.
According to the FDA, patients who use an inhaler containing CFCs should talk to their healthcare provider about an alternative treatment.
New drug for treatment of pulmonary hypertension
Riociguat (Adempas) has been approved by the FDA for the treatment of adults with two forms of pulmonary hypertension. Riociguat is indicated for patients with chronic thromboembolic pulmonary hypertension (CTEPH) after surgery or patients who cannot undergo surgery, to improve their ability to exercise. The drug is also indicated for patients with pulmonary arterial hypertension (World Health Organization Group 1) to improve their ability to exercise and to delay clinical worsening of the condition.
Riociguat belongs to a class of drugs called soluble guanylate cyclase stimulators, which promotes vasodilation and helps increase blood flow and decrease BP. It is the first drug in its class approved to treat two types of pulmonary hypertension.
Riociguat carries a Boxed Warning alerting patients and healthcare professionals that the drug should not be used in pregnant women because it can harm the fetus. Female patients can receive the drug only through the risk evaluation and mitigation strategy (REMS) program.
Common adverse reactions associated with riociguat in clinical trials included headache, dizziness, dyspepsia, peripheral edema, nausea, diarrhea, and vomiting.
Adempas is marketed by Bayer HealthCare Pharmaceuticals, Inc.
Label change explains risks with ezogabine
The FDA approved changes to the labeling of the antiseizure medication ezogabine (Potiga) to make healthcare professionals and patients aware of previously reported risks for retinal abnormalities, potential vision loss, and skin, nail, scleral, and mucous membrane discoloration–all of which may become permanent.
The new Boxed Warning states that ezogabine should be stopped in patients who do not show a substantial clinical benefit after adequate drug titration. If retinal or vision changes are noted, ezogabine should be stopped, unless no other treatment options are available and the treatment benefits outweigh the potential risks.
The FDA further recommended that patients undergo eye examinations conducted by an ophthalmology professional prior to starting ezogabine and every 6 months during treatment. These exams should include visual acuity and dilated fundus photography, with additional vision testing as needed. Generally, patients whose vision cannot be monitored should not take the drug.