FDA Approves Adhansia XR

Topics: Adhansia XR | ADHD | adolescents | Attention Deficit Hyperactivity Disorder | Child Psychiatry | children | extended-release | methylphenidate | News of Note | pediatric | teens | treatment

We are always in need of a new formulation of stimulant medication that might capture a few more of our patients who just do not quite tolerate or respond well enough to the many existing formulations. So whenever a new one is released, we try to set aside our natural skepticism and take a look at the stated facts before judging its merit. Adhansia X

First Non-Drug Treatment Approved by FDA for Treating Children With ADHD

Topics: ADHD | adolescents | Attention Deficit Hyperactivity Disorder | Brain Devices | Child Psychiatry | children | efficacy | eTNS | News of Note | pediatric | safety | teens | treatment | Trigeminal Nerve Stimulation

NeuroSigma made a splash by announcing that the FDA has granted medical device approval for its external Monarch Trigeminal Nerve Stimulation (eTNS) System for treating kids with ADHD ages 7–12 who are not currently taking medications. What does medical device approval mean? The FDA reviewed the Monarch eTNS System through the de novo ­pre-market

New Generic Versions of Naloxone

Topics: Addiction | Addiction Treatment | Clinical practice | Medication | Naloxone | News of Note | Opioid epidemic | Opioid Use Disorder | Opioids | Overdose | Pharmacology

Naloxone, a rescue medication effective for reversing opioid overdoses, will soon be available in two generic forms for layperson use. Naloxone nasal spray is the generic version of branded Narcan Nasal, which currently sells for $150 for two doses. The generic version will be much cheaper. Naloxone auto-injector is the generic version of Evzio au

Opioid Use Disorder: Is There an App for That?

Topics: Addiction | Addiction Treatment | Clinical practice | Cognitive Behavioral Therapy | News of Note | Opioid epidemic | Opioid Use Disorder | Opioids | Technology

In December 2018, the FDA announced its approval of reSET-O, a new mobile medical app marketed by Pear Therapeutics to treat opioid use disorder (OUD). Mobile medical apps (MMAs) are a rapidly expanding class of smartphone apps intended to improve patient health and wellness. The FDA defines MMAs as software programs that run on smartphones and “trans

Lybalvi: The Diet Olanzapine

Topics: Antipsychotics | Metabolic syndrome | Metformin | News of Note | Novel drug | Obesity | olanzapine | Side Effects | Waist circumference | Weight gain | Weight Loss Medications

Lybalvi is a new combo pill that aims to overcome the dreaded metabolic effects of olanzapine by pairing it with the opioid antagonist samidorphan. Patients still gain weight on Lybalvi, though not as much as they do on olanzapine. In the three controlled trials that compared the two drugs, the weight gain on Lybalvi was 5 lb less at six months, 3 lb le

In the News: Aducanumab (Aduhelm)

Topics: Aducanumab | Aduhelm | Cognition | Cognitive Decline | Complementary treatments | Dementia | Neurology | News of Note | Novel drug

Alzheimer’s disease (AD) is devastating. There is no cure and existing treatments don’t slow or stop its progression. In June 2021, the FDA approved aducanumab (pronounced a-due-KAN-you-mab, brand name Aduhelm) for the treatment of AD. It’s the first new AD med since 2003 and is the only treatment that directly attacks a component of AD’s purpor

Lumateperone and lemborexant

Topics: Antipsychotics | Belsomra | Caplyta | Dayvigo | Hypnotics | Lemborexant | Lumateperone | News of Note | Orexin | Pharmacology | Psychopharmacology | Suvorexant

Two new psychiatric medications were approved in the final days of 2019. One is the first of its kind, an antipsychotic with minimal dopaminergic blockade: lumateperone (Caplyta). The other is lemborexant (Dayvigo), a variation on the hypnotic suvorexant (Belsomra). Lumateperone (Caplyta)Though classified as an atypical antipsychotic, lumateperone is u

Meet the First H3 Antagonist

Topics: Histamine | Narcolepsy | Neurology | News of Note | Pitolisant | Wakix

On August 15, 2019, pitolisant (Wakix) received FDA approval for narcolepsy, making it the first release of a histamine-3 (H3) antagonist. Unlike other narcolepsy medications, pitolisant is not a controlled substance and lacks abuse potential. Those other options for narcolepsy are the stimulants (methylphenidate and amphetamine), the modafinils, sodiu

An Antipsychotic Patch

Topics: Antipsychotic | Asenapine | News of Note | Patch | Saphris | Secuado | Transdermal

Asenapine (Saphris) is now available as a transdermal patch, Secuado. The patch showed efficacy in a large 6-week, double-blind, placebo-controlled, fixed-dose study in 616 adult patients with schizophrenia. Transdermal medications are thought to reduce side effects by avoiding “first-pass” metabolism in the GI tract. This is unlikely to be an adva

A New Contraindication for Ambien and the Z-Hypnotics

Topics: FDA Warnings | Hypnotics | Insomnia | News of Note | Practice Tools and Tips | Psychopharmacology | Psychopharmacology Tips | Sleep

“Complex sleep behavior” is a euphemism for various problems that can happen after ingesting a sleeping pill. They range from cooking and emailing to driving a car or even sexual assault, all done in an amnestic state that is not recalled upon awakening. In 2007 the FDA placed warnings about these behaviors on all medications approved for insomnia,

A New Treatment for Bipolar Depression

Topics: Antipsychotics | Atypical Antipsychotics | Bipolar Depression | Bipolar Disorder | Depression | News of Note | Pharmacology | Psychopharmacology

On May 28, 2019, cariprazine (Vraylar) became the fourth atypical antipsychotic to receive FDA approval for bipolar depression. The approval was based on two randomized controlled trials involving 1,051 patients and lasting 6–8 weeks. These studies grouped patients into fixed doses from 0.75–3 mg/day. The sweet spot seems to be 1.5 mg/day, which was

An Opioid Combo Falls Short in Depression

Topics: Depression | News of Note

Opioids have a bad name these days. But let’s not forget that they were once consid­ered a first-line treatment for depression before the discovery of MAOIs and tricy­clics in the 1950s. That history has been revived recently by buprenorphine, a par­tial opioid agonist that was fast-tracked by the FDA for treatment-resistant depression. Buprenorphi

Brexanolone: A New Treatment for Postpartum Depression

Topics: News of Note

There is a need for rapid treatment in postpartum depression, as each month of this potentially severe condition can take a toll on infant development. That is why brexanolone (Zulresso), which was recently fast-tracked for approval by the FDA, is causing such a splash. Brexanolone is a neurosteroid that activates GABAA receptors. It was originally d

FDA Approves Lucemyra—But Is It Better Than Clonidine?

Topics: News of Note

On May 16, 2018, the FDA announced its approval of Lucemyra (lofexidine) as a drug to help patients withdraw from opioids. Like clonidine, lofexidine is an alpha-2 agonist, but it is touted as causing less orthostatic hypotension and therefore being somewhat safer to use. To put this in perspective, it’s important to note that buprenorphine is the

New Approvals for TMS

Topics: Brain Devices | News of Note

We know that transcranial magnetic stimulation (TMS) works for treatment-resistant depression (TRD) (see TCPR July/August 2017 for our most recent coverage), but one disadvantage is the length of the treatment sessions. We also don’t know if TMS works for other disorders. Recently, the FDA granted new approvals that address both these issues. One a

Jornay PM Nighttime Stimulant for Next-Morning Effect

Topics: ADHD | News of Note | Sleep Disorders

Prescribing bedtime stimulants sounds like a recipe for a bad night’s sleep. But the FDA recently approved Jornay PM, which is an extended release (ER) formulation of methylphenidate that is, in fact, dosed at night. Approved for kids age 6 and older, Jornay PM has an extremely delayed onset of effect of 10 hours. This means kids can take it at aro

FDA Approves First Drug to Treat Tardive Dyskinesia

Topics: News of Note | Psychopharmacology

On April 11, the U.S. Food and Drug Administration approved Ingrezza (valbenazine) for the treatment of tardive dyskinesia (TD), a disabling movement disorder that afflicts 10%–20% of people on chronic antipsychotic ­medication. The approval was based on a clinical trial in which 234 patients with moderate to severe TD were randomly assigned to a

A Kratom Update

Topics: Addiction | News of Note | Substance Abuse

If you have not yet heard of kratom (usually pronounced kray-tom or krah-tom), consider this an introduction to an herbal supplement that will likely be popping up in your newsfeeds with increasing frequency. Kratom (Mitragyna speciosa) is a tropical evergreen tree in the coffee family that has been used for centuries in Southeast Asia to boost energy a

Concerta: Brand vs Generic

Topics: Child Psychiatry | News of Note | Pharmaceutical Industry | Psychopharmacology

In November 2016, the FDA announced that it was requiring two companies to withdraw their generic versions of Concerta (OROS methylphenidate) because of efficacy concerns. Such actions are quite unusual, and when they occur, they tend to shake doctors’ confidence in the generic drug system—which branded drug companies are often eager to encourage. B

Before You Write That Prescription: Guidelines for Ordering Lab Tests

Topics: Laboratory Testing in Psychiatry | News of Note | Practice Tools and Tips | Psychopharmacology Tips

Mental health clinicians often ask for a single, black-and-white answer to the question: Which lab tests should I order before starting this particular medication? Inevitably, the answer is that it depends. However, there are some guidelines that are useful. When it comes to ordering lab tests, it sometimes feels like we are “damned if we do, and d