The FDA's regulatory pathway for monotherapy
use(1), which was communicated in September 2016, states that "it is acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of partial-onset seizures to their use as monotherapy
for the treatment of partial-onset seizures." Fycompa is the first AED to be approved as monotherapy
for partial-onset seizures in accordance with this regulatory pathway.
Although the study didn't meet its clinical endpoints in the overall cohort of 891 patients with mild-moderate Alzheimer's disease, TauRx promoted it as "promising," based on a subgroup analysis of patients who took the drug as monotherapy
. None of these patients were taking any standard-of-care Alzheimer's medications; the press release did not say how many this group comprised.
Although the study didn't meet its clinical endpoints in the overall cohort of 891 patients with mild-moderate disease, TauRx promoted it as "promising," based on a subgroup analysis of the 15% of patients who took the drug as monotherapy
OBJECTIVE: Evaluate the efficacy of L-methylfolate in combination with SSRI or SNRI compared to SSRI or SNRI monotherapy
in a major depressive episode.
Glycopyrrolate, a long-acting muscarinic antagonist, is available as monotherapy
. The FDA also has granted the long-acting beta-2 agonist formoterol fumarate tentative approval for use as monotherapy
This review will focus on the available monotherapy
approaches to RA and include data from TNF inhibitors (TNFi) and recently approved biologics such as interleukin (IL)-6 receptor blockers and the small molecules (JAK inhibitors).
A/INSUFFICIENT EVIDENCE exists to determine which specific combinations most effectively decrease cardiovascular morbidity and mortality, although combinations of hypertension medications at lower doses generally reduce cardiovascular outcomes (stroke, coronary heart disease) more than monotherapy
(strength of recommendation [SOR]: A, large meta-analyses).
COMBINATION THERAPY BEATS MONOTHERAPY
The current randomised controlled trial was designed to assess the efficacy of this natural gum as a monotherapy
or in combination with pantoprazole (a proton pump inhibitor) and compare this with the standard regime.
The patients were then randomized to treatment: 169 infliximab monotherapy
, 170 azathioprine monotherapy
, or 169 infliximab plus azathioprine combination therapy.
Erbitux was also approved for use alone (monotherapy
) to treat patients whose head and neck cancer has spread (metastasized) despite the use of standard chemotherapy.
The majority of the women (504) were on AED monotherapy