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A Mometasone-Eluting Sinus Implant (Sinuva) for Nasal Polyps
The Medical Letter on Drugs and Therapeutics • Sep 10, 2018 (Issue 1555)
sinus surgery; it is marketed by the same manufacturer
as Sinuva.1
Pronunciation Key
Sinuva: sigh new ...
The FDA has approved Sinuva (Intersect ENT), a sinus
implant that gradually releases the corticosteroid
mometasone furoate over a 90-day period, for
treatment of nasal polyps in adults who have had
ethmoid sinus surgery. Propel, a sinus implant that
releases mometasone furoate over 30 days, is FDA-approved
to maintain the sinus opening after ethmoid
sinus surgery; it is marketed by the same manufacturer
as Sinuva.
Obiltoxaximab (Anthim) for Inhalational Anthrax
The Medical Letter on Drugs and Therapeutics • Sep 10, 2018 (Issue 1555)
with levofloxacin alone. In macaques, a single
16 mg/kg IM dose of obiltoxaximab alone administered
1-3 days ...
The FDA has approved obiltoxaximab (Anthim –
Elusys Therapeutics), a toxin-targeting monoclonal
antibody, for treatment of inhalational anthrax in
combination with antibacterial drugs and prophylaxis
of inhalational anthrax when other therapies are
unavailable or inappropriate. Raxibacumab, another
monoclonal antibody, was approved earlier for the
same indication. Like raxibacumab, obiltoxaximab
is being manufactured only for the CDC national
stockpile and is not available for commercial sale.
Osmolex ER - Another Extended-Release Amantadine for Parkinson's Disease
The Medical Letter on Drugs and Therapeutics • Sep 10, 2018 (Issue 1555)
of levodopa-induced
dyskinesia in patients with PD.1
Pronunciation Key
Osmolex: oz' mole ex
STANDARD ...
The FDA has approved an extended-release tablet
formulation of amantadine (Osmolex ER – Vertical/Osmotica) for once-daily treatment of Parkinson's
disease (PD) and drug-induced extrapyramidal
symptoms (EPS) in adults. An extended-release
capsule formulation of amantadine (Gocovri) was
approved in 2017 for treatment of levodopa-induced
dyskinesia in patients with PD.
Lutetium Lu 177 Dotatate (Lutathera) for Gastroenteropancreatic Neuroendocrine Tumors (online only)
The Medical Letter on Drugs and Therapeutics • Sep 10, 2018 (Issue 1555)
with lutetium Lu 177
dotatate plus octreotide than with high-dose octreotide
alone in the NETTER-1 trial ...
The FDA has approved lutetium Lu 177 dotatate (Lutathera – Advanced Accelerator Applications), a radiolabeled somatostatin analog, for treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEPNETs) in adults.
Management of Opioid Withdrawal Symptoms
The Medical Letter on Drugs and Therapeutics • Aug 27, 2018 (Issue 1554)
infection. Several guidelines on management
of opioid withdrawal are available.1-3 Maintenance
treatment ...
Pharmacologic management of opioid withdrawal
symptoms can reduce the intensity of drug craving
and improve treatment retention in patients with opioid
use disorder who will receive maintenance treatment.
Withdrawal management without subsequent maintenance
treatment is associated with high rates of
relapse, overdose death, and HIV and/or hepatitis C
virus infection. Several guidelines on management
of opioid withdrawal are available. Maintenance
treatment of opioid use disorder was reviewed in a
previous issue.
Two New Intra-Articular Injections for Knee Osteoarthritis
The Medical Letter on Drugs and Therapeutics • Aug 27, 2018 (Issue 1554)
and placebo.1
CLINICAL STUDIES — Approval of Durolane was
based on the results of a randomized, double-blind ...
The FDA has approved a single-injection hyaluronic
acid gel (Durolane – Bioventus) and an extended-release
(ER) formulation of the synthetic corticosteroid
triamcinolone acetonide (Zilretta – Flexion) for intra-articular
(IA) treatment of osteoarthritic knee pain.
Expanded Table: Some Drugs for Management of Opioid Withdrawal Symptoms (online only)
The Medical Letter on Drugs and Therapeutics • Aug 27, 2018 (Issue 1554)
symptoms (COWS score
~11-12)
Taper in decrements of 10-20%
every 1-2 days; some patients,
particularly ...
View Expanded Table: Some Drugs for Management of Opioid Withdrawal Symptoms
In Brief: More Fluoroquinolone Warnings
The Medical Letter on Drugs and Therapeutics • Aug 13, 2018 (Issue 1553)
and mental health effects
associated with their use.1
An FDA review identified 67 cases of hypoglycemic ...
The FDA has required changes in the labeling of all systemic fluoroquinolone antibiotics to strengthen warnings about the risk of severe hypoglycemia and mental health effects associated with their use.1An FDA review identified 67 cases of hypoglycemic coma associated with fluoroquinolone use, 22 of which resulted in death or disability. Most cases occurred in patients with risk factors such as diabetes (especially those taking a sulfonylurea), older age, or renal insufficiency.1 In observational studies in older adults and patients with diabetes, fluoroquinolones have been associated with...
Biktarvy - Another INSTI-Based Combination for HIV
The Medical Letter on Drugs and Therapeutics • Aug 13, 2018 (Issue 1553)
), for treatment of HIV-1
infection in adults. The new combination is indicated for
use in patients who ...
The FDA has approved Biktarvy (Gilead), a once-daily,
fixed-dose combination of bictegravir, a new integrase
strand transfer inhibitor (INSTI), and the nucleoside
reverse transcriptase inhibitors (NRTIs) emtricitabine
and tenofovir alafenamide (TAF), for treatment of HIV-1
infection in adults. The new combination is indicated for
use in patients who are antiretroviral-naive or who have
been virologically suppressed on a stable antiretroviral
regimen for ≥3 months with no history of treatment
failure and no known substitutions associated with
resistance to any component of the...
Ciprofloxacin Otic Suspension (Otiprio) for Acute Otitis Externa
The Medical Letter on Drugs and Therapeutics • Aug 13, 2018 (Issue 1553)
Ciprofloxacin Otic Suspension
Otiprio) for Acute Otitis Externa
Table 1. Some Otic ...
The FDA has approved a 6% otic suspension
formulation of the fluoroquinolone antibiotic
ciprofloxacin (Otiprio – Otonomy) for single-dose
treatment of acute otitis externa (swimmer's
ear) caused by Pseudomonas aeruginosa or
Staphylococcus aureus in patients ≥6 months old.
Otiprio was approved earlier for prophylaxis in
children with bilateral otitis media with effusion who
are undergoing tympanostomy tube placement.