1
In Brief: Alternatives to Adderall
The Medical Letter on Drugs and Therapeutics • November 28, 2022; (Issue 1664)
The short-acting formulation of mixed amphetamine
salts (Adderall, and generics) FDA-approved for
treatment of attention-deficit hyperactivity disorder
(ADHD) and narcolepsy, is currently in short supply in
the US. Until an adequate supply is restored, patients
may be looking for alternatives.
2
Antiviral Drugs for COVID-19 in Vaccinated Outpatients
The Medical Letter on Drugs and Therapeutics • March 6, 2023; (Issue 1671)
Three products are currently available in the US for
treatment of high-risk,1 nonhospitalized adults with
mild to moderate COVID-19: oral ritonavir-boosted
nirmatrelvir (Paxlovid), IV remdesivir (Veklury), and
oral molnupiravir (Lagevrio). Remdesivir is FDA-approved
for such use; nirmatrelvir/ritonavir and
molnupiravir are available under an FDA Emergency
Use Authorization. Because the pivotal clinical trials
of these products for outpatient use were conducted
in patients who were not vaccinated against
COVID-19, some clinicians have questioned whether
they can benefit vaccinated outpatients.
3
Live Fecal Microbiota (Rebyota) for Prevention of CDI Recurrence
The Medical Letter on Drugs and Therapeutics • March 6, 2023; (Issue 1671)
The FDA has approved Rebyota (Ferring), a rectally-administered,
live fecal microbiota suspension, for
prevention of additional recurrences of Clostridioides
difficile infection (CDI) following antibiotic treatment
for a recurrent episode of CDI in adults. Rebyota is
the first microbiome-based treatment to be approved
for this indication. It is not approved for initial
treatment of CDI. Fecal microbiota transplantation
(FMT) has been used in patients with multiple
CDI recurrences.
4
In Brief: Off-Label Amitriptyline for Insomnia
The Medical Letter on Drugs and Therapeutics • March 20, 2023; (Issue 1672)
In our article on Drugs for Chronic Insomnia, we said
there is little evidence that antidepressants such as
trazodone, mirtazapine, or amitriptyline are effective
in treating insomnia not associated with depression.
We received a comment from a reader who has
prescribed the tricyclic antidepressant amitriptyline
for insomnia, particularly for patients with headache
disorders, and finds that most patients are satisfied
with the treatment.
5
Drugs for Overactive Bladder
The Medical Letter on Drugs and Therapeutics • March 20, 2023; (Issue 1672)
In overactive bladder, involuntary bladder contractions
due to detrusor overactivity result in urinary
urgency, frequency, nocturia, and incontinence.
The prevalence of the disorder increases with age.
Nonpharmacologic treatment, including bladder
training, urge suppression, pelvic floor muscle
exercises, constipation management, modification of
fluid intake, and avoidance of dietary irritants such as
alcohol and caffeine, should be tried first.
6
Ublituximab (Briumvi) for Relapsing Multiple Sclerosis
The Medical Letter on Drugs and Therapeutics • March 6, 2023; (Issue 1671)
The FDA has approved the recombinant chimeric
anti-CD20 antibody ublituximab-xiiy (Briumvi – TG Therapeutics) for IV treatment of adults with
relapsing forms of multiple sclerosis (MS), including
clinically isolated syndrome (initial neurological
episode), relapsing-remitting disease, and active
secondary progressive MS (SPMS). Two other anti-CD20 antibodies, IV ocrelizumab (Ocrevus) and SC
ofatumumab (Kesimpta), are also FDA-approved for
these indications.
7
Elacestrant (Orserdu) for Advanced or Metastatic Breast Cancer
The Medical Letter on Drugs and Therapeutics • March 6, 2023; (Issue 1671)
The FDA has approved elacestrant (Orserdu –
Stemline), an oral estrogen receptor antagonist, for
treatment of estrogen receptor (ER)-positive, human
epidermal growth factor receptor 2 (HER2)-negative,
estrogen receptor 1 (ESR1)-mutated advanced or
metastatic breast cancer in postmenopausal women
or men who had disease progression following
endocrine therapy. Elacestrant is the first oral selective
estrogen receptor degrader (SERD) to be approved
for treatment of breast cancer; the injectable SERD
fulvestrant (Faslodex, and generics) was approved
more than 20 years ago.
8
Terlipressin (Terlivaz) for Hepatorenal Syndrome
The Medical Letter on Drugs and Therapeutics • March 20, 2023; (Issue 1672)
The FDA has approved the intravenously administered
synthetic vasopressin analog terlipressin (Terlivaz –
Mallinckrodt) to improve kidney function in adults
with hepatorenal syndrome (HRS) and a rapid decline
in kidney function. Terlipressin is the first drug to be
approved for this indication in the US; it has been
available in Europe and elsewhere for year
9
A Dexamethasone Ophthalmic Insert (Dextenza) for Allergic Conjunctivitis
The Medical Letter on Drugs and Therapeutics • March 20, 2023; (Issue 1672)
The FDA has approved Dextenza (Ocular Therapeutix),
a dexamethasone ophthalmic insert, for
treatment of ocular itching associated with allergic
conjunctivitis. Dextenza was approved earlier for
treatment of ocular inflammation and pain following
ophthalmic surgery.
10
In Brief: A New Breast Cancer Indication for Sacituzumab Govitecan (Trodelvy) (online only)
The Medical Letter on Drugs and Therapeutics • March 6, 2023; (Issue 1671)
Sacituzumab govitecan-hziy (Trodelvy – Gilead) has
been approved for treatment of unresectable locally
advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2
(HER2)-negative breast cancer in adults who received
prior endocrine therapy and ≥2 additional systemic
therapies for metastatic disease. It was previously
approved for treatment-refractory metastatic triplenegative
breast cancer and for treatment of locally
advanced or metastatic urothelial cancer in adults
who received platinum-based chemotherapy and a
programmed death receptor-1 (PD-1) or programmed
death-ligand 1 (PD-L1) inhibitor.