1
Airsupra: An Inhaled Albuterol/Budesonide Combination for Asthma
The Medical Letter on Drugs and Therapeutics • March 18, 2024; (Issue 1698)
The FDA has approved Airsupra (AstraZeneca), a
metered-dose inhaler containing the short-acting
beta2-agonist (SABA) albuterol and the inhaled
corticosteroid (ICS) budesonide, for use as needed for
treatment or prevention of bronchoconstriction and to
reduce the risk of exacerbations in patients ≥18 years
old with asthma. Airsupra is the first combination of
a SABA and an ICS to become available in the US. It is
not approved for use as maintenance therapy.
2
In Brief: A New OTC Naloxone Nasal Spray (RiVive)
The Medical Letter on Drugs and Therapeutics • March 18, 2024; (Issue 1698)
The FDA has approved RiVive (Harm Reduction
Therapeutics), a 3-mg naloxone nasal spray, as
an over-the-counter (OTC) product for emergency
treatment of opioid overdose. Two 4-mg naloxone
nasal spray formulations, Narcan and one of its
generics, were approved for OTC sale in 2023.
3
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.
4
Penbraya: A Pentavalent Meningococcal Vaccine
The Medical Letter on Drugs and Therapeutics • March 18, 2024; (Issue 1698)
The FDA has licensed Penbraya (Pfizer), a pentavalent
polysaccharide conjugate meningococcal
vaccine, for prevention of invasive meningococcal
disease caused by Neisseria meningitidis
serogroups A, B, C, W, or Y (MenABCWY) in persons
10-25 years old. Penbraya is the only meningococcal
vaccine that contains all five of these serogroups.
Two quadrivalent polysaccharide conjugate
meningococcal vaccines containing serogroups A,
C, W, and Y (MenACWY; Menveo, MenQuadfi) and
two meningococcal serogroup B vaccines (MenB;
Bexsero, Trumenba) are available in the US (see
Table 2).
5
Mirikizumab (Omvoh) for Ulcerative Colitis
The Medical Letter on Drugs and Therapeutics • March 18, 2024; (Issue 1698)
The FDA has approved the interleukin (IL)-23
antagonist mirikizumab-mrkz (Omvoh – Lilly) for
treatment of moderately to severely active ulcerative
colitis (UC) in adults. Mirikizumab is the first selective
IL-23 antagonist to be approved for this indication.
Ustekinumab (Stelara), an IL-12/23 antagonist, was
approved for treatment of UC in 2019. The IL-23
antagonist risankizumab (Skyrizi) is approved for
treatment of Crohn's disease.
6
Addendum: Bupropion Safety in Pregnancy
The Medical Letter on Drugs and Therapeutics • April 1, 2024; (Issue 1699)
Our December 11, 2023 article on Drugs for Depression included a single sentence on the safety of bupropion use during
pregnancy: "The safety of bupropion during pregnancy has
not been established; data from a bupropion pregnancy registry
suggested a possible increase in cardiac malformations."
A reader asked us to provide more information.
7
Drugs for Bipolar Disorder
The Medical Letter on Drugs and Therapeutics • April 1, 2024; (Issue 1699)
Bipolar disorder is characterized by episodes of
mania, hypomania, and depression. Recurrences of
manic or (more frequently) depressive symptoms
are common. About 15-20% of patients with bipolar
disorder die by suicide.
8
In Brief: Severe Hypocalcemia with Denosumab (Prolia) in Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • March 4, 2024; (Issue 1697)
The FDA is requiring a boxed warning in the label
of denosumab (Prolia – Amgen), a monoclonal
antibody that inhibits osteoclasts, about an
increased risk of severe hypocalcemia in patients
with advanced chronic kidney disease (CKD;
eGFR <30 mL/min/1.73 m2), particularly those on
dialysis. FDA-approved indications for Prolia are
listed in Table 1.
9
Omalizumab (Xolair) for Food Allergy
The Medical Letter on Drugs and Therapeutics • April 1, 2024; (Issue 1699)
Omalizumab (Xolair – Genentech), a recombinant
anti-IgE monoclonal antibody FDA-approved for
treatment of allergic asthma, chronic rhinosinusitis
with nasal polyps, and chronic urticaria, has now
also been approved for use in conjunction with food
allergen avoidance to reduce IgE-mediated food
allergic reactions caused by accidental exposure in
patients ≥1 year old. Omalizumab is the first drug to
be approved in the US to reduce allergic reactions to
more than one food. Palforzia, an oral peanut allergen
powder, was approved in 2020 to mitigate allergic
reactions caused by accidental peanut exposure in
patients with a confirmed peanut allergy.
10
Drugs for Menopausal Symptoms
The Medical Letter on Drugs and Therapeutics • March 4, 2024; (Issue 1697)
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.