Patient Acceptability of INP104 Aligns With the Unmet Needs Identified in the I-BEAM Survey
posted in Presentations by Brooke Eger
Presented at PAINWeek Conference, September 7-11, 2021, Las Vegas, NV, USA
Authors: Jessica Ailani, MD, Kate Kennedy, ARNP-BC, TinaMarie Lieu, PhD, John Hoekman, PhD, Maria Jeleva, PhD, Sutapa Ray, Stephen B. Shrewsbury, MB ChB, Sheena K. Aurora, MD
Purpose: Migraine is an undertreated disease despite the availability of acute therapies and patients continue to report dissatisfaction with treatment. Oral treatment is most often prescribed, but migraine-associated autonomic dysfunction of the gastrointestinal tract, with or without accompanying symptoms, is increasingly being recognized as a potential limitation to oral administration of drugs; thus, non-oral options are increasingly being identified as important alternatives. INP104 is a novel, investigational drug-device combination product that targets delivery of dihydroergotamine mesylate (DHE) to the upper nasal space using Precision Olfactory Delivery (POD®) technology. Upper nasal space drug delivery may provide greater, more consistent absorption and reliable symptom relief. The safety and tolerability of delivery to this previously unexplored area are important, but just as important is understanding patient acceptability of the POD device. The safety, tolerability, and exploratory efficacy of INP104 for the acute treatment of migraine were assessed in the Phase 3 STOP 301 study over 24 or 52 weeks. As part of the STOP 301 trial, the acceptability of INP104 was evaluated through a patient acceptability questionnaire (PAQ). The results of the questionnaire were interpreted in the context of unmet needs evaluated through a patient survey and interview in the I-BEAM study. Here we report unmet needs in the treatment of migraine from the perspective of individuals with migraine as assessed by the I-BEAM study and product acceptability of INP104 over 24 weeks from the pivotal Phase 3 STOP 301 clinical trial.
Methods: The I-BEAM study consisted of surveys and interviews with participants to better understand patient experiences, including satisfaction levels with current treatments and unmet needs. The survey-responsive population was 98% female, aged 20-50 years, experiencing 1-12 migraine attacks per month who “always” or “sometimes” took prescription medication for their migraine attacks within the previous 6 months. Recruitment was conducted through social media and referrals (N=50). A 15-minute quantitative survey (n=50) was administered to obtain diagnosis and treatment information, and a 1-hour qualitative interview was conducted (n=49) either as an in-person individual-depth interview (n=24) or a web-enabled telephone-depth interview (n=25) to obtain more detailed insight into perspectives surrounding diagnosis and treatment. The STOP 301 study was an open-label, multicenter, Phase 3 safety study of repetitive INP104 self-administration for the acute treatment of migraine. Patients completed a 9-question PAQ at the end of 24 or 52 weeks. Results from 6 of these questions are reported here. The remaining 3 questions were related to dysgeusia, discomfort in the nose, and determining if patients would ask their doctors for a prescription once available, which were not relevant to their unmet need. Patients were asked to answer “Strongly Disagree; Disagree; Neutral; Agree; Strongly Agree” (or Not Applicable) to the following questions about INP104 once they had completed the study: (1) The study drug is easy to use; (2) With the investigational product I can return to normal activities faster (school/work/leisure activities) compared to my previous prescription migraine medication(s); (3) Compared to my previous prescription migraine medications, the investigational product more consistently relieves each one of my migraine headaches; (4) The investigational product works faster compared to my previous prescription migraine medication(s); (5) The investigational product keeps my migraine from coming back for a longer time than previous prescription migraine medications I’ve used; and (6) The investigational product was very convenient to carry with me and use outside of my home. Both the I-BEAM survey (2019) and the STOP 301 study (2018-2020) were performed prior to the launch of gepants and ditans.
Results: The I-BEAM survey participants reported that the most frequent features lacking with their current migraine treatments were speed of relief (22%), reliability of effect (22%), and duration of relief (18%). The most frequently mentioned features of an ideal acute medication for migraine included fast acting (15-30 minutes), long lasting (12-24 hours), providing complete or near complete relief, ability to be taken any time during the migraine, having few or no side effects (although many patients were willing to accept minor side effects as a trade-off for increased speed and efficacy), and one medication to relieve all symptoms. The STOP 301 study included 354 patients who received at least 1 dose of INP104 over the first 24 weeks, of whom 74% of patients completed 24 weeks of treatment. Results from the PAQ demonstrated that most patients agreed or strongly agreed that INP104 was easy to use (84%), and compared to their previous treatment 54% of patients agreed or strongly agreed that INP104 allowed them to return to normal activities faster, 56% that INP104 worked faster, 55% that INP104 worked more consistently, and 54% that INP104 lasted longer.
Conclusion: INP104 may provide an effective, well-tolerated acute treatment for migraine. Most patients reported INP104 was easy to use; provided faster acting, consistent benefit with longer lasting relief; and allowed them to return to normal activities faster than their previous treatment. These PAQ results align with the unmet needs identified by the I-BEAM survey: (1) Fast acting (15-30 minutes); (2) long lasting (12-24 hours); (3) providing complete or near complete relief; (4) can be taken any time; (5) with few/no side effects. The INP104 clinical development program led to the submission of an NDA in November 2020, which is currently under FDA review.
Citation: Ailani J, Kennedy K, Lieu TM, Hoekman J, Jeleva M, Ray S, Shrewsbury SB, Aurora SK, Patient Acceptability of INP104 Aligns With the Unmet Needs Identified in the I-BEAM Survey, PAINWeek Conference, September 7-11, 2021