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Pharma & Bio Ingredients
Reductions in average daily pain scores from baseline to the end of treatment based on the 11 point Likert pain scale were statistically significant with once daily Gabapentin GR. Clinically significant improvements in the pain score were observed with a mean change from baseline to study end of -2.45 compared to -1.26 for placebo (p= 0.002). Although not statistically significantly different for twice daily Gabapentin GR, there was pain improvement with a reduction in mean daily pain score of -1.75 with Gabapentin GR compared to -1.26 with placebo (p= 0.190). These data were calculated using a baseline observation carried forward analysis, meaning that a zero percent improvement was assigned to patients who did not complete the study.
The secondary endpoint analysis of responders, defined as patients with at least a 50 percent reduction in pain at endpoint compared to baseline, showed that both once and twice daily Gabapentin GR arms reached statistical significance. The proportion of responders was 35 percent for once daily Gabapentin GR (p= 0.001), 26 percent for twice daily Gabapentin GR (p= 0.015) and 8 percent for placebo.
"These results are impressive and position Gabapentin GR favorably in efficacy, safety and dosing convenience against existing therapeutic options which are dosed at least three times per day," said John W. Fara, Ph.D., chairman, president and chief executive officer of Depomed. "The data strongly support once daily Gabapentin GR and indicate that twice daily dosing may also be an option for patients. We are enthusiastic about sharing these data with companies that have expressed an interest in partnering Gabapentin GR with us and are encouraged to advance our development program for DPN forward."
Sherwyn Schwartz, M.D., clinical investigator in the trial and director, Diabetes & Glandular Disease Research Associates of San Antonio, said, "The pharmacodynamic properties of Gabapentin GR provide long lasting drug exposure to help manage the pain. This is especially important with Gabapentin GR given once daily with an evening meal as pain is generally more pronounced in patients at night. Patients are being dosed at what appears to be an optimal time with a controlled release formulation that provides extended pain relief throughout the day."
Sleep interference, another secondary endpoint, decreased with both once and twice daily Gabapentin GR, with the once daily Gabapentin GR reaching statistical significance. In the once daily arm, Sleep Interference Scores were reduced by -2.70 compared to -1.65 with placebo (p=0.01).
There were no serious adverse events associated with Gabapentin GR. The most common side effects observed were dizziness and somnolence, which are commonly associated with gabapentin. The reported incidences were 17.0 percent and 12.8 percent for dizziness and somnolence respectively for once daily Gabapentin GR and 12.2 percent and 4.1 percent, respectively for twice daily Gabapentin GR. In each of the three treatment groups, once and twice daily Gabapentin GR and placebo, there were only two patients who discontinued the study due to adverse events.
