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Monthly News Roundup - March 2019

Mayzent First Oral Treatment Approved for Active Secondary Progressive MS

In March the U.S. Food and Drug Administration (FDA) approved Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis (MS), which includes clinically isolated syndrome (CIS), relapsing remitting disease, and active secondary progressive MS (SPMS).

  • Mayzent is classified as a sphingosine-1-phosphate (S1P) receptor modulator. Drug cost is set at $88,000 per year.
  • In the Phase III EXPAND study, a placebo-controlled clinical trial of 1,651 patients with SPMS, Mayzent significantly lowered disease progression, number of relapses and physical and cognitive decline. In patients with non-active SPMS, the results were not statistically significant.
  • The most common side effects were headache, high blood pressure and elevated liver function tests.

FDA Clears Mavenclad Tablets for Relapsing Multiple Sclerosis

At the end of March, the FDA approved Mavenclad (cladribine), a purine antimetabolite indicated for the treatment of relapsing forms of multiple sclerosis (MS). Its uses include relapsing-remitting disease and active secondary progressive disease.

  • Mavenclad is not recommended for MS patients with clinically isolated syndrome or as a first-line agent.
  • Efficacy was demonstrated in a clinical trial with 1,326 patients. Mavenclad significantly decreased the number of relapses and the progression of disability in these patients compared to placebo.
  • Common adverse reactions include upper respiratory tract infections, headache and decreased white blood cell counts. Mavenclad should not be used in patients with an active cancer.

Sunosi Approved for Daytime Sleepiness Linked With Two Sleep Disorders

This month the FDA approved once-daily Sunosi (solriamfetol) from Jazz Pharmaceuticals, the first selective dopamine and norepinephrine reuptake inhibitor (DNRI) used to improve wakefulness and reduce excessive daytime sleepiness in adults with obstructive sleep apnea (OSA) or narcolepsy.

  • Narcolepsy results in the inability to regulate sleep-wake cycles, while obstructive sleep apnea (OSA) leads to breathing pauses during sleep due to airway narrowing or blockage.
  • In placebo-controlled studies at Week 12, Sunosi oral tablets demonstrated improvements in wakefulness compared to placebo as assessed at one hour and nine hours after the dose.
  • Common side effects with Sunosi include headache, nausea, decreased appetite, and anxiety.
  • DEA controlled substance scheduling is in process for this agent.

FDA OKs Oral Jatenzo for Certain Forms of Hypogonadism

Jatenzo (testosterone undecanoate) from Clarus Therapeutics is now approved as an oral testosterone replacement therapy for the treatment of low testosterone in men with hypogonadism.

  • Jatenzo is indicated for men with genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland, but not “age-related hypogonadism” due to heart safety risks.
  • In a 4-month study of 166 men with hypogonadism, 87% of Jatenzo-treated men reached testosterone levels within the normal range, which was the primary study endpoint.
  • Common side effects include headache, an increase in hematocrit (red blood cell count), a decrease in high-density lipoprotein cholesterol (“good” cholesterol), high blood pressure and nausea.
  • Jatenzo contains a boxed warning about increased risk of blood pressure elevations, heart attack, stroke and cardiovascular death.

Spravato Nasal Spray Offers Novel Antidepressant Mechanism

The FDA has approved Janssen’s Spravato (esketamine), a rapidly-acting non-competitive N-methyl D-aspartate (NMDA) receptor antagonist that is used with an oral antidepressant for adults with treatment-resistant major depressive disorder (MDD).

  • In Phase 3 studies of over 1,700 adults, all patients received an oral antidepressant, and either intranasal placebo or esketamine. In the group that received Spravato, superior improvement in depression symptoms was seen at four weeks compared to the placebo plus oral antidepressant group. However, most of Spravato’s treatment difference compared to placebo was observed at 24 hours instead of several weeks, as with many other antidepressants.
  • Patients receiving Spravato plus an oral antidepressant were also 51% less likely to relapse as compared to patients on placebo nasal spray plus an oral antidepressant.
  • The most common side effects were disassociation (feeling detached from one’s surroundings), dizziness, and nausea, among others.
  • Spravato is a Schedule III controlled substance and will only be available through a restricted distribution system (REMS). Patients will receive the drug only at a certified doctor's office and cannot take the drug home.
  • Ketamine, a prescription anesthetic related to esketamine, is abused as the club drug known as "Special K".

FDA Approves Zulresso as First Treatment For Postpartum Depression

This month, the FDA approved Zulresso (brexanolone) injection from Sage Therapeutics for the treatment of postpartum depression (PPD) in adult women. PPD leads to symptoms of sadness, withdrawal, lack of self-worth, reduced maternal-infant bond or suicidality.

  • Zulresso is a gamma-aminobutyric acid A (GABA-A) receptor positive allosteric modulator and is the first drug specifically approved for PPD.
  • It is given as an intravenous (IV) infusion over 60 hours (2.5 days) in a certified health care facility and is prescribed via a restricted REMS program due to possible loss of consciousness in the patient.
  • In clinical studies, Zulresso demonstrated superiority to placebo in improvement of moderate and severe PPD symptoms at the end of the first infusion and at the end of a 30-day follow-up period.
  • Side effects include sleepiness, dry mouth, loss of consciousness and flushing.

Posted: March 2019