Medication Monitor



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  • March 6, 2019

    FDA has approved esketamine nasal spray, in conjunction with an oral antidepressant, to treat depression in adults who have not benefited from other antidepressants. Esketamine is the s-enantiomer of ketamine ([Ketalar] approved in 1970), which is a mixture of two enantiomers (mirror-image molecules). This is the first FDA approval of esketamine for any use.

    Because of the potential for serious adverse outcomes resulting from sedation and dissociation, the drug will be available only through a restricted distribution system under a Risk Evaluation and Mitigation Strategy (REMS). Esketamine must also be dispensed with a patient Medication Guide that outlines the drug’s uses and risks. 

    Patients self-administer esketamine nasal spray under the supervision of a health care provider in a certified doctor’s office or clinic, and the spray cannot be taken home. The health care provider instructs the patient on how to operate the nasal spray device. During and after each use of the nasal spray device, the health care provider will check the patient and determine when the patient is ready to leave. Patients must be monitored by a health care provider for at least 2 hours after receiving their esketamine dose.  

    Efficacy of esketamine was evaluated in three short-term (4-week) clinical trials and one longer-term maintenance-of-effect trial. In the three short-term studies, patients were randomized to receive esketamine or a placebo nasal spray. In light of the serious nature of treatment-resistant depresison and the need for patients to receive some form of treatment, all patients in these studies started a new oral antidepressant at the time of randomization, and the new antidepressant was continued throughout the trials. The primary efficacy measure was the change from baseline on a scale used to assess the severity of depressive symptoms.

    In one of the short-term studies, esketamine nasal spray demonstrated statistically significant effect compared with placebo on the severity of depression, and some effect was seen within 2 days. The two other short-term trials did not meet the prespecified statistical tests for demonstrating effectiveness. In the longer-term maintenance-of-effect trial, patients in stable remission or with stable response who continued treatment with esketamine plus an oral antidepressant experienced a statistically significantly longer time to relapse of depressive symptoms than patients on placebo nasal spray plus an oral antidepressant.

    The most common adverse effects in clinical trials were disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity, anxiety, lethargy, increased blood pressure, vomiting, and feeling drunk.

    Patients with unstable or poorly controlled hypertension or preexisting aneurysmal vascular disorders may be at increased risk for adverse cardiovascular or cerebrovascular effects. Esketamine may impair attention, judgment, thinking, reaction speed, and motor skills. Patients should not drive or operate machinery until the next day after a restful sleep. Because the drug may cause fetal harm, women of reproductive potential should consider pregnancy planning and prevention, and women should not breastfeed while being treated.

    FDA granted this drug application Fast Track and Breakthrough Therapy designations.

  • February 27, 2019

    FDA approved antihemophilic factor (recombinant), glycopegylated-exei, for adults and children with hemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. It comes as a lyophilized powder for solution for I.V. use.

    Approval was based on results from a clinical trial program that included 270 previously treated people with severe hemophilia A and more than 5 years of clinical exposure. The biologic provided effective routine prophylaxis in people with severe hemophilia A through a simple, fixed dosing regimen of one injection every 4 days in adults and adolescents or every 3 to 4 days (twice weekly) in children. It was well tolerated, and no safety concerns were identified.

    The most frequently reported adverse reactions (≥1%) were rash, redness, itching, and injection-site reactions.

    Novo Nordisk is expected to launch the product in 2020.

  • February 26, 2019

    Novartis announced FDA approval of triclabendazole for treatment of fascioliasis in patients aged 6 years and older. 

    Fascioliasis, commonly known as liver fluke infestation, is a neglected tropical disease that infects 2.4 million people worldwide, with an additional 180 million at risk of infection. It is caused by two species of parasitic flatworms that can infect humans following ingestion of larvae in contaminated water or food.

    Left untreated, fascioliasis can result in considerable pain and discomfort, leading to poor quality of life and loss of productivity. In the acute phase of the disease, patients experience fever, abdominal pain, nausea, diarrhea, and eosinophilia. The disease later progresses to a latent phase with fewer symptoms and ultimately into a chronic or obstructive phase. In children, fascioliasis can be a serious infection with high fever, enlarged tender liver, and anemia. 

    Triclabendazole is currently the only medicine for fascioliasis recommended by the World Health Organization (WHO) and is on the WHO Model List of Essential Medicines. It is supplied by WHO during epidemic outbreaks and for periodic use in endemic countries.

    FDA's approval of triclabendazole is expected to facilitate drug licensing and import to these countries, helping to ensure sufficient and prompt availability of the drug when needed.

  • February 7, 2019

    FDA approved caplacizumab-yhdp injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting.

    Patients with aTTP develop extensive blood clots in the small blood vessels throughout the body. These clots can cut off oxygen and blood supply to the major organs and cause strokes and heart attacks that may lead to brain damage or death. Patients can develop aTTP because of conditions such as cancer, HIV, pregnancy, lupus or infections or after having surgery, bone marrow transplantation, or chemotherapy.

    Common adverse effects reported by patients in clinical trials were bleeding of the nose or gums and headache. The prescribing information for caplacizumab-yhdp includes a warning to advise health care providers and patients about the risk of severe bleeding.

    Health care providers are advised to monitor patients closely for bleeding when administering the drug to patients who currently take anticoagulants.

  • February 6, 2019

    Evolus announced FDA approval of prabotulinumtoxinA-xvfs, an acetylcholine release inhibitor and a neuromuscular blocking agent that temporarily improves the appearance of moderate to severe frown lines between the eyebrows (glabellar lines) associated with corrugator and/or procerus muscle activity in adults.

    Approval was supported by clinical data from two Phase III randomized, multicenter, double-blind, placebo-controlled clinical trials. Both trials met the primary endpoint and demonstrated efficacy compared with placebo in the reduction of severity of glabellar lines, defined as a 2-point composite improvement agreed upon by physician and patient, at day 30.

    Dosage is 0.1 mL (four units) by I.M. injection into each of five sites, for a total dose of 20 units.

    The product may cause rare but serious adverse effects that can be life-threatening, including problems swallowing, speaking, or breathing due to weakening of associated muscles and spread of toxin effects.

    The most common adverse effects include headache, eyelid drooping, upper respiratory tract infection, and increased white blood cell count.

    The product is expected to be available in spring 2019.

     

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