The FDA has approved a second extended-release (ER) formulation of the oral opioid agonist hydrocodone (Hysingla ER – Purdue) for management of pain severe enough to require continuous long-term therapy and for which alternative treatment options are inadequate. Hysingla ER tablets have abuse-deterrent properties to discourage their misuse.

The FDA has approved the monoamine oxidase type B (MAO-B) inhibitor safinamide (Xadago – US Worldmeds) as an adjunct to levodopa/carbidopa for management of "off" episodes in patients with Parkinson’s disease (PD). It is the first reversible MAO-B inhibitor to be approved for this indication. Selegiline (Eldepryl, and others) and rasagiline (Azilect, and generics), two irreversible MAO-B inhibitors, have been used alone and as adjuncts to levodopa/carbidopa for many years. Safinamide is not approved for use as monotherapy.

Oliceridine (Olinvyk - Trevena), an IV opioid agonist, has been approved by the FDA for management of acute pain severe enough to require an opioid and for which alternative treatment options are inadequate.

Gabapentin (Neurontin - Pfizer), which has been available in the US since 1994, is approved by the FDA only for treatment of partial epilepsy and postherpetic neuralgia, but is widely used off-label for a number of other indications, especially neuropathic pain syndromes. According to one report, among Medicaid recipients in Florida receiving gabapentin, 71% of prescriptions were for chronic pain and 8% for seizures and neuralgia ("The Pink Sheet" February 2, 2004; 66:30).

The FDA has approved Namzaric (Forest), a fixed-dose combination of extended-release (ER) memantine (Namenda XR), an NMDA-receptor antagonist, and donepezil (Aricept, and generics), an acetylcholinesterase inhibitor, for treatment of moderate to severe Alzheimer's type dementia in patients previously stabilized on both drugs. The patent for Namenda has recently expired and generic formulations of memantine 5- and 10-mg tablets have been approved.

The FDA has approved Apadaz (KemPharm), a short-acting, fixed-dose combination of benzhydrocodone and acetaminophen, for short-term management (≤14 days) of acute pain severe enough to require an opioid and for which alternative treatment options are inadequate. Benzhydrocodone is a prodrug of hydrocodone. Fixed-dose combinations of short-acting hydrocodone and acetaminophen or ibuprofen have been available for years and are the most abused opioid products in the US. Apadaz was developed under the presumption that inclusion of the inactive prodrug would reduce the potential for...

A selective serotonin reuptake inhibitor (SSRI) is generally used for initial treatment of major depressive disorder (MDD). A serotonin-norepinephrine reuptake inhibitor (SNRI), bupropion (Wellbutrin SR, and others), and mirtazapine (Remeron, and others) are reasonable alternatives. Improvement in symptoms can occur within the first two weeks of treatment with these drugs, but a substantial benefit may not be achieved for 4-8 weeks.

Oral antipsychotic drugs used for treatment of schizophrenia, schizoaffective disorder, delusional disorder, and other manifestations of psychosis or mania are listed in Table 1. Parenteral antipsychotic drugs used for treatment of these disorders are listed in Table 2.

The primary symptoms of menopause are genitourinary and vasomotor. The genitourinary syndrome of menopause (GSM) includes symptoms such as burning, irritation, dryness, dyspareunia, dysuria, and recurrent urinary tract infection. Vasomotor symptoms (VMS; hot flashes, night sweats) often disrupt sleep.

The FDA has approved the marketing of fesoterodine (Toviaz - Pfizer), a muscarinic receptor antagonist, for treatment of overactive bladder. It is the sixth antimuscarinic drug approved for this indication.