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Onexton Gel for Acne
The Medical Letter on Drugs and Therapeutics • Aug 31, 2015 (Issue 1476)
and the oxidizing
agent benzoyl peroxide (Onexton Gel 1.2%/3.75% –
Valeant) for topical treatment of acne ...
The FDA has approved another fixed combination of
the antibiotic clindamycin phosphate and the oxidizing
agent benzoyl peroxide (Onexton Gel 1.2%/3.75% –
Valeant) for topical treatment of acne in patients ≥12
years old. Topical products containing the same drugs
have been available for many years. Onexton Gel
contains a new strength of benzoyl peroxide.
Alirocumab (Praluent) to Lower LDL-Cholesterol
The Medical Letter on Drugs and Therapeutics • Aug 17, 2015 (Issue 1475)
of ≥50%, for patients with clinical
atherosclerotic cardiovascular disease.1 The National
Lipid ...
The FDA has approved the subcutaneously injected
PCSK9 (proprotein convertase subtilisin kexin type 9)
inhibitor alirocumab (Praluent – Sanofi/Regeneron)
as an adjunct to diet and maximally tolerated
statin therapy for adults with heterozygous familial
hypercholesterolemia (HeFH) or clinical atherosclerotic
cardiovascular disease who require additional lowering
of LDL-cholesterol (LDL-C). It was not approved for
general use in statin-intolerant patients. Alirocumab
is the first PCSK9 inhibitor to be approved in the US.
Evolocumab (Repatha – Amgen), another PCSK9
inhibitor, was...
Brexpiprazole (Rexulti) for Schizophrenia and Depression
The Medical Letter on Drugs and Therapeutics • Aug 17, 2015 (Issue 1475)
when
adherence is a problem.1
Table 1. Pharmacology
Class Second-generation antipsychotic
Mechanism ...
The FDA has approved the oral, once-daily, second-generation
antipsychotic brexpiprazole (Rexulti –
Otsuka/Lundbeck) for treatment of schizophrenia
and as an adjunct to antidepressants for treatment
of major depressive disorder (MDD). Aripiprazole
(Abilify), a structurally similar second-generation
antipsychotic also comarketed by Otsuka (with BMS),
recently became available generically.
Palbociclib (Ibrance) for Metastatic Breast Cancer
The Medical Letter on Drugs and Therapeutics • Aug 17, 2015 (Issue 1475)
Table 1. Pharmacology
Class CDK 4 and 6 inhibitor
Formulation 75, 100, 125 mg capsules
Route Oral ...
Palbociclib (Ibrance – Pfizer), an oral cyclin-dependent
kinase inhibitor, has been approved by the FDA for use
in combination with the aromatase inhibitor letrozole
(Femara, and generics) for first-line treatment of
postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. It is the
first cyclin-dependent kinase inhibitor to become
available in the US.
Panobinostat (Farydak) for Multiple Myeloma (online only)
The Medical Letter on Drugs and Therapeutics • Aug 17, 2015 (Issue 1475)
(PANORAMA1) in 768 patients with relapsed
or refractory multiple myeloma who had received
1-3 previous ...
The FDA has approved panobinostat (Farydak –
Novartis), an oral histone deacetylase (HDAC) inhibitor,
for use in combination with bortezomib (Velcade) and
dexamethasone for treatment of patients with multiple
myeloma who have received at least 2 prior therapies
including bortezomib and an immunomodulatory
drug. It is the first HDAC inhibitor to be approved for
this indication.
Lenvatinib (Lenvima) for Thyroid Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Aug 17, 2015 (Issue 1475)
inhibitor and
in those who had not (median progression-free
survival 15.1 and 18.7 months, respectively ...
The FDA has approved the oral multikinase inhibitor
lenvatinib (Lenvima – Eisai) for treatment of locally
recurrent or metastatic, progressive, differentiated
thyroid cancer (papillary or follicular) refractory to
radioactive iodine treatment.
Rifaximin (Xifaxan) for Irritable Bowel Syndrome with Diarrhea
The Medical Letter on Drugs and Therapeutics • Aug 03, 2015 (Issue 1474)
that
has not responded to fiber and laxatives.1,2
MECHANISM OF ACTION — Rifaximin is a minimally
absorbed, broad ...
Rifaximin (Xifaxan – Salix), a minimally absorbed
oral antibiotic approved previously to treat travelers'
diarrhea and to reduce the risk of recurrent hepatic
encephalopathy, has now been approved by the FDA
for treatment of irritable bowel syndrome with diarrhea
(IBS-D). Eluxadoline (Viberzi – Actavis), a mu-opioid
receptor agonist, was also recently approved for IBS-D
and will be reviewed in a future issue.
In Brief: Duopa - A Carbidopa/Levodopa Enteral Suspension for Parkinson's Disease
The Medical Letter on Drugs and Therapeutics • Aug 03, 2015 (Issue 1474)
hours with immediaterelease
tablets.1
Duopa is available in a 100-mL single-use cassette
containing ...
The FDA has approved Duopa (Abbvie), a carbidopa/levodopa enteral suspension, for treatment of motor fluctuations in patients with advanced Parkinson's disease (PD). It has been available in Europe since 2001.In patients with advanced PD, emptying of the stomach may be delayed and unpredictable, which can affect the rate and amount of absorption of carbidopa/levodopa and its efficacy. To bypass the stomach, the new formulation is delivered through a nasojejunal (NJ) tube or percutaneous endoscopic gastrostomy with jejunal (PEG-J) tube.A randomized, double-blind, active-controlled, 12-week...
Sacubitril/Valsartan (Entresto) for Heart Failure
The Medical Letter on Drugs and Therapeutics • Aug 03, 2015 (Issue 1474)
for patients who cannot
tolerate an ACE inhibitor.1
MECHANISM OF ACTION — Neprilysin is a neutral ...
The FDA has approved Entresto (Novartis), an oral
fixed-dose combination of the neprilysin inhibitor
sacubitril and the angiotensin receptor blocker (ARB)
valsartan, to reduce the risk of cardiovascular death
and heart failure hospitalization in patients with
heart failure with reduced ejection fraction. Sacubitril
is the first neprilysin inhibitor to become available in
the US.
Polidocanol (Varithena) for Varicose Veins
The Medical Letter on Drugs and Therapeutics • Aug 03, 2015 (Issue 1474)
and stripping.1
A meta-analysis of 13 randomized controlled
trials in ˃3000 patients with great saphenous ...
An injectable foam formulation of the sclerosing
agent polidocanol (Varithena – Provensis/BTG)
has been approved by the FDA for treatment of
incompetent veins and visible varicosities of the great
saphenous vein system. It is the first foam therapy to
be approved for this indication, but polidocanol and
other sclerosants have been used for years as foam
formulations compounded by physicians. Polidocanol
is also available in a liquid formulation (Asclera)
to treat smaller veins. Sodium tetradecyl sulfate
(Sotradecol) is FDA-approved in a liquid formulation
for use in...