The maximal dose
was used in 36% of sertraline patients, compared with 54% of hypericum patients.
In its comments, the company disagrees with CMS' proposal to limit coverage in important conditions such as myelodysplasia or myelodysplastic syndrome (MDS), and disagrees with the agency's proposals regarding treatment initiation, duration of treatment and maximal dose
based on substantial clinical evidence.
In fact, in 71% of patients treated with the dose of pradefovir that is expected to be used in a Phase III trial, viral DNA levels, a measure of viral load, were reduced to undetectable levels, approximately double what was seen with a maximal dose
of the marketed hepatic B drug Hepsera.
Approximately 58 percent of patients randomized to 400 mg/day achieved this maximal dose
in the monotherapy controlled trial; the mean dose achieved in the trial was 275 mg/day.
Overall ralfinamide was well tolerated up to the maximal dose
with absence of any consistent pattern of clinically relevant adverse events regarding vital signs, ECG and other laboratory values.
In addition to the 13-week rat study, Omeros has conducted several nonclinical studies with OMS824 in rats and in primates, including a 13Caeweek nonclinical study in primates, at equally high drug exposures to those resulting from the maximal dose
in the rat study, with no findings similar to the observation reported from the most recent study in rats.
This is equivalent to the lower maximal dose
proposed by EMA for adolescents (i.
2) Doses in this study exceed the currently FDA-approved maximal dose
of 75 mg daily.
If pain persists after 6 weeks of therapy, increase medication to maximal dose
and add a second or even third medication to the regimen.
The maximal dose
of a drug and steady state are different in nonpregnant and pregnant patients, of course, because drug clearance is higher during pregnancy.
Martin et al reported a 55% 28 day survival in 57 patients receiving a mean (standard deviation) maximal dose
1) These results showed that an intensive strategy including first systematically prescribing the sulfonylurea gliclazide modified release, up to the maximal dose
of 4 tablets per day, and then progressively other conventional drugs, lowers blood glucose levels safely to hemoglobin A1c levels of 6.