Lead Indication
Prevention of Nausea and Vomiting Associated with Motion
Our initial development program seeks to enhance the power of scopolamine through a novel intranasal delivery system. As the lead indication for our platform molecule DPI-386, we are exploring both the benefits and risks of rapid absorption to prevent nausea and vomiting associated with motion.
Study Design
To date, 6 clinical trials designed to evaluate the efficacy, safety, and pharmacokinetics of DPI-386 versus placebo have been completed to date. More than 1,160 patients have participated in these trials.
Study Title
Primary Endpoint
Participants
DPI-386-MS-21
NCT03986905
3
A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of DPI-386 Nasal Gel on Ocean Going Vessels for the Prevention and Treatment of Nausea Associated with Motion Sickness
Incidence of subjects who developed motion sickness and requested further treatment
297 patients,
aged 18-59 years
DPI-386-MS-22
NCT04184115
3
A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of the Safety, Efficacy and Pharmacokinetics of DPI-386 Nasal Gel for the Prevention and Treatment of Nausea Associated with Motion Sickness
Incidence of subjects who developed motion sickness and requested further treatment
102 patients,
aged 18-59 years
DPI-386-MS-24
NCT03988530
3
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety, Efficacy and Pharmacokinetics of DPI-386 Nasal Gel for the Prevention and Treatment of Nausea Associated with Motion Sickness in Senior Subjects with Open-Label Follow-Up
Incidence of subjects who developed motion sickness and requested further treatment
Session 1 included 83 subjects, aged 55+ years,
Session 2 included 18 additional subjects > or = 70 years of age)
C98-047 (106.0598)
3
A Randomized, Single-Dose, Double-Blind, Placebo-Controlled Pivotal Study to Establish the Safety and Efficacy of Scopolamine Hydrobromide Delivered as a Nasal Gel Preparation for the Treatment (Relief) of Motion Sickness on a Short-Term Cruise
No vomiting and no retching during the 3-hour period
114 patients,
aged 19-59 years
DPI-386-MS-29
NCT04947423
3
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated with Motion
Participants who report no vomiting within 4 hours after receiving study drug and no use of rescue treatment (e.g., dimenhydrinate) within 4 hours after receiving study drug (Time Frame: 4 hours)
140 patients,
aged 18-70 years
DPI-386-MS-31
NCT04947423
3
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated with Motion
Complete response study (no vomiting/no rescue) vs placebo
150 patients,
aged 18-70 years
DPI-386-MS-31
3
A Phase 1, Randomized, Open-Label, Crossover Study to Assess the Relative Bioavailability and Safety of Scopolamine Administered as the DPI-386 Nasal Gel and Scopolamine Transdermal System (Transderm Scōp) in Healthy Participants
Bioavailability and safety of DPI-386 compared to the TDS patch
20 patients,
aged 18-55 years
DPI-386-MS-33
NCT05548270
3
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of DPI-386 Nasal Gel for the Prevention of Nausea and Vomiting Associated with Motion
Proportion of Participants Who Report no Vomiting Within 4 Hours or to end of voyage, whichever comes later after Receiving Study Drug and no Use of Rescue Treatment (Time Frame: 4 hours)
503 patients,
aged 18 years and older
Key Clinical Takeaways
In these trials:
- The intranasal scopolamine gel provided a rapid, statistically significant reduction in motion sickness symptoms compared with placebo
- There was no statistically significant difference in adverse events (AEs) between the intranasal scopolamine and placebo groups
- There was no statistically significant difference between the intranasal scopolamine and placebo groups in all modules of the Automated Neuropsychological Assessment Metrics (ANAM)*
- Intranasal scopolamine showed significantly less anticholinergic AEs than the scopolamine patch
*ANAM is a proven military tool designed to detect speed and accuracy of attention, memory, and thinking ability.
Fast-Acting Potential
In our clinical trials, the intranasal scopolamine gel reached a peak plasma concentration after 50 minutes. The scopolamine patch reached the same peak plasma concentration after 10 hours. Based on our trials, we expect the intranasal gel to provide fast-acting prevention of nausea and vomiting associated with motion sickness.
DPI-386 has not been approved by the FDA.
We continue to explore the potential of intranasal scopolamine in a broad range of indications.
