October 3, 2011
Otonomy issued results from a phase Ib trial of OTO-104 for Meniere's disease. This randomized, placebo-controlled, multicenter study enrolled 44 subjects with unilateral Meniere's disease. The subjects received OTO-104 (3mg or 12mg) or placebo administered as a single intratympanic injection. During a one month baseline period, the subjects experienced an average of eight days with definitive vertigo episodes. Following a single intratympanic injection, subjects in the 12 mg OTO-104 group experienced a month-over-month reduction in vertigo frequency throughout the three month follow-up period, and achieved an approximate six day reduction in the number of definitive vertigo days in the third month versus baseline. When compared to placebo, the 12 mg study group experienced a 70% greater reduction from baseline in the number of days with definitive vertigo episodes. In addition, both the 3 mg and 12 mg OTO-104 doses were associated with improvement in tinnitus. This improvement was seen as early as one month following treatment and continued throughout the entire three month follow-up period.
November 10, 2008
Chelsea Therapeutics reported positive interim data from a phase III trial of droxidopa for the treatment of neurogenic orthostatic hypotension (NOH). This randomized, placebo-controlled, induction-design, four-week trial planned to enroll 118 subjects across international sites. Prior to randomization, all subjects were to be undergo a two-week, open-label dose titration period, during which they would receive up to 600 mg of droxidopa three times daily (tid). All subjects who responded to treatment subsequently underwent a seven day washout period, followed by double-blind randomization to droxidopa or placebo treatment for one week. Results are from the first 35 subjects to complete the open label dose titration phase. Data revealed a clear improvement across all doses of Droxidopa up to 600 mg tid. The average Orthostatic Hypotension Symptom Assessment Scale (OHSA) baseline score for responders prior to treatment was 6.4 and the average score at the end of the titration was 1.8. In addition, a mean improvement in standing systolic blood pressure (SBP) of 27 mmHg was observed. This improvement was achieved with only a modest impact on supine blood pressure, with mean standing SBP increasing 32.4% compared to only a 13.8% increase in mean supine SBP. The double-blind, randomized portion of the study is currently underway.
January 15, 2007
Chelsea reported positive preliminary results from a phase II trial of droxidopa for the treatment of neurogenic orthostatic hypotension. This double-blind, randomized, placebo-controlled, parallel group trial enrolled 125 subjects in Europe under the direction of Christopher Mathias, D Phil, DSc, FRCP, Professor of Neurovascular Medicine, Imperial College School of Medicine at St. Mary's Hospital, London. Subjects received either placebo or Droxidopa three times daily (tid) in doses ranging from 100 mg to 300 mg, for 28 days. The primary endpoint was to determine the optimal dose of Droxidopa in the treatment of orthostatic hypotension in subjects with multiple system atrophy (MSA) or Parkinson's Disease (PD). Treatment was well tolerated with little difference in adverse events between the droxidopa and placebo groups. Statistical significance in reducing the fall in orthostatic systolic blood pressure (SBP) was demonstrated at 300 mg tid with the difference in SBP being 11.6 mm Hg between the groups. Based on these results, phase III trials are undergoing development.