The FDA has approved injection of onabotulinumtoxinA (Botox – Allergan) for prevention of headaches in adult patients with chronic migraine (≥15 headache days/month for ≥3 months). It is the first drug approved for treatment of this indication. Botox is also FDA-approved for treatment of upper limb spasticity, axillary hyperhidrosis, cervical dystonia, blepharospasm and strabismus, and for cosmetic reduction of wrinkles.

Previously approved by the FDA for treatment of depression, general anxiety disorder, diabetic peripheral neuropathic pain and fibromyalgia, duloxetine (Cymbalta – Lilly) has now also been approved for treatment of chronic musculoskeletal pain.

The opioid agonist tramadol is now available in an oral solution (Qdolo – Athena Bioscience) for management of pain severe enough to require an opioid and for which alternative treatment options are inadequate. Tramadol has been available for years in immediate-release tablets and capsules, extended-release capsules (Ultram, and others), and in a fixed-dose combination tablet with acetaminophen (Ultracet, and generics).

The FDA has approved erenumab-aooe (Aimovig – Amgen/Novartis), a once-monthly, subcutaneously-injected, monoclonal antibody against the calcitonin gene-related peptide receptor, for preventive treatment of migraine in adults. It is the first drug in its class to be approved by the FDA.

The FDA has approved pitolisant (Wakix – Harmony), a histamine-3 (H₃)-receptor antagonist/inverse agonist, for treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. It is the first H₃-receptor antagonist/inverse agonist to become available in the US and the first non-controlled substance to receive FDA approval for these indications. Pitolisant has been available in Europe since 2016.

Irritable bowel syndrome (IBS) is a common disorder characterized by recurrent abdominal pain and altered bowel habits, often accompanied by bloating. IBS is classified by its predominant bowel symptom: constipation (IBS-C), diarrhea (IBS-D), mixed type (IBS-M), or unclassified (IBS-U). Since the exact cause of IBS is unknown, the goal of treatment is symptom control. Some over-the-counter (OTC) products and prescription drugs for IBS are listed in Tables 1-4. The safety of these drugs during pregnancy and lactation is described in Table 5 (online only).

Although lithium (Eskalith, and others) is the standard treatment for bipolar (manic-depressive) disorder, 20% to 40% of patients do not respond adequately or cannot tolerate its adverse effects (Medical Letter, 33:43, 1991). Results of recent studies suggest that valproate (Depakene - valproic acid; Depakote - divalproex sodium), a widely used anticonvulsant (Medical Letter, 31:1, 1989), might be an effective alternative. Other anticonvulsants, particularly carbamazepine (Tegretol, and others), have also been used as second-line drugs for treatment of mania and other psychiatric ...

Midodrine hydrochloride (ProAmatine - Roberts), an alpha1-selective adrenergic agonist, is now available for treatment of severe symptomatic orthostatic hypotension. Other treatments for this condition include other sympathomimetics, constrictive garments, erythropoietin (Epogen; Procrit) and fludrocortisone with salt (D Robertson and TL Davis, Neurology, 45 suppl 5: S26, 1995).

Results from a double-blind trial suggest that off-label use of the oral antihyperglycemic drug metformin in patients with COVID-19 may decrease the risk of post-acute sequelae of SARS-CoV-2 infection ("long COVID").

A combination of the corticosteroid budesonide and the long-acting beta₂-agonist formoterol (Symbicort - AstraZeneca) has become available in a metered dose inhaler for long-term maintenance treatment of asthma in patients ≥ 12 years old. A combination product that contains fluticasone propionate and salmeterol (Advair) is already available for this indication in the US. Neither one of these combinations is approved for acute treatment of asthma symptoms. A dry powder inhaler formulation of Symbicort has been available in Europe and Canada for several years.