Medication Monitor

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  • April 9, 2019

    FDA approved testosterone undecanoate, an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical conditions, such as genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland.

    Testosterone undecanoate should not be used to treat men with age-related hypogonadism, in which testosterone levels decline due to aging, even if these men have symptoms that appear to be related to low testosterone. The drug's benefits do not outweigh its risks for that use, according to FDA.

    Efficacy was demonstrated in a 4-month clinical trial involving 166 men with hypogonadism. Study participants initially were given 237 mg of testosterone undecanoate twice per day, and the dose was adjusted downward or upward to a maximum of 396 mg twice per day on the basis of testosterone levels.

    Eighty-seven percent of men treated with the drug achieved an average testosterone level within the normal range, which was the primary study endpoint.

    Testosterone undecanoate contains a boxed warning stating that the drug can cause blood pressure to rise, increasing the risk of heart attack, stroke, and cardiovascular death. Health care providers should consider a patient’s individual heart disease risks and ensure that blood pressure is adequately controlled before prescribing the agent. They should also periodically monitor patient blood pressure during treatment.

    The drug is currently one of two testosterone products that have this boxed warning. FDA is requiring all testosterone product manufacturers to conduct blood pressure postmarketing trials to more clearly address whether these products increase blood pressure.

    Common adverse effects, occurring in more than 2% of patients in the clinical trial, included headache, an increase in red blood cell count, a decrease in HDL-C, high blood pressure, and nausea. An increase in prostate specific antigen (PSA) was also observed. Patients should have their hematocrit, cholesterol, and PSA monitored regularly to check for changes. Those with benign prostate hyperplasia should be monitored for worsening of symptoms.

  • March 27, 2019

    FDA has approved siponimod for treatment of adults with relapsing forms of multiple sclerosis (MS), including secondary progressive multiple sclerosis (SPMS) with active disease, relapsing remitting multiple sclerosis, and clinically isolated syndrome. SPMS is a debilitating form of MS characterized by progressive and irreversible neurological disability. Patients will not require a first dose observation (cardiac monitoring upon initiation) unless they have certain preexisting cardiac conditions.

    Approval was based on groundbreaking data from the Phase III EXPAND study, a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of siponimod versus placebo in people living with SPMS. Patients enrolled in EXPAND were representative of a typical SPMS population. At study initiation, patients had a mean age of 48 years and had been living with MS for approximately 16 years. More than 50% had a median Expanded Disability Status Scale score of 6.0 and relied on a walking aid.

    Siponimod significantly reduced the risk of 3-month confirmed disability progression (CDP), meaningfully delayed the risk of 6-month CDP, and reduced the annualized relapse rate by 55%. Furthermore, EXPAND showed significant favorable outcomes in other relevant measures of MS disease activity, including cognition, MRI disease activity, and brain volume loss.

    The most common adverse reactions (incidence >10%) were headache, hypertension, and transaminase increase.

  • March 27, 2019

    Jazz Pharmaceuticals announced FDA approval of solriamfetol to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). It is the first dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) approved for this treatment.

    The once-daily drug is approved in doses of 75 mg and 150 mg for patients with narcolepsy and doses of 37.5 mg, 75 mg, and 150 mg for patients with OSA. 

    Approval of solriamfetol was based on data from the TONES Phase III clinical program, which included four randomized placebo-controlled studies that demonstrated the superiority of solriamfetol relative to placebo. The most common adverse reactions reported in both the narcolepsy and OSA study populations were headache, nausea, decreased appetite, and anxiety. Solriamfetol was evaluated in more than 900 adults with excessive daytime sleepiness associated with narcolepsy or OSA and was shown to maintain its effect relative to placebo after 6 months of use.

    In 12 week clinical studies, approximately 68%–74% of people taking solriamfetol at the 75 mg dose and 78%–90% of people taking solriamfetol at the 150 mg dose reported improvement in their overall clinical condition, as assessed by the Patient Global Impression of Change scale.

    Although the exact mechanism of action is unknown, the effects of solriamfetol are thought to be mediated through its activity as a DNRI.

    In a news release, Jazz Pharmaceuticals cautioned that solriamfetol is not indicated to treat the underlying airway obstruction in OSA. Practitioners should ensure that the underlying airway obstruction is treated with continuous positive airway pressure (CPAP) for at least 1 month before initiating solriamfetol for excessive daytime sleepiness in OSA and continued during treatment.

  • March 27, 2019

    FDA approved brexanolone injection for I.V. use for treatment of postpartum depression (PPD) in adult women. This is the first drug approved by FDA specifically for PPD.

    Brexanolone will be available only through a restricted REMS Program that requires the drug to be administered by a health care provider in a certified health care facility. The REMS requires that patients be enrolled in the program prior to administration of the drug.

    Brexanolone is administered as a continuous I.V. infusion over 60 hours (2.5 d). Because of the risk of serious harm from sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. While receiving the infusion, patients must be accompanied during interactions with their child(ren). The need for these steps is addressed in a boxed warning in the drug’s prescribing information.

    Patients will be counseled on the risks of brexanolone treatment and instructed that they must be monitored for these effects at a health care facility for the entire 60 hours of infusion. Patients should not drive, operate machinery, or do other dangerous activities until feelings of sleepiness from the treatment have completely gone away.

    Brexanolone's effectiveness was shown in two clinical studies in participants who received a 60-hour continuous I.V. infusion of brexanolone or placebo and were then followed for 4 weeks. One study included patients with severe PPD, and the other included patients with moderate PPD. The primary measure in the study was the mean change from baseline in depressive symptoms as measured by a depression rating scale.

    In both placebo-controlled studies, brexanolone demonstrated superiority to placebo in improvement of depressive symptoms at the end of the first infusion. The improvement in depression was also observed at the end of the 30-day follow-up period. 

    The most common adverse reactions reported by patients included sleepiness, dry mouth, loss of consciousness, and flushing. Health care providers should consider changing the therapeutic regimen, including discontinuing brexanolone in patients whose PPD becomes worse or who experience emergent suicidal thoughts and behaviors.

  • 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.