P-053 - (Poster #53) Listening to Patients with Diabetic Peripheral Neuropathic Pain: Insights from a Patient Survey to Inform Advanced Clinical Development of Pilavapadin

Diabetic neuropathy is one of the most common and prevalent complications of both type 1 and type 2 diabetes. As patients continue living with diabetes, it is estimated that up to 50% develop neuropathy during their lifetime.  Diabetic peripheral neuropathic pain (DPNP) occurs in 25-30% of diabetes patients.  The most prevalent form of diabetic neuropathy is distal symmetric polyneuropathy, which is characterized by burning pain, tingling, numbness, paresthesia, hyperalgesia, and allodynia. These debilitating symptoms significantly impact quality of life, including depression, sleep disturbance, and daily functioning. Many challenges exist in management of DPNP, most notably a lack of timely diagnosis. This presents a large unmet need highlighting the necessity for innovative therapeutic approaches.

Purpose/Objectives:

The purpose of this research was to better understand the patient experience living with DPNP, uncover the unmet treatment needs in treatment and management of DPNP, and incorporate these learnings into the development of the pilavapadin phase 3 clinical trial program.

Methods:

A patient survey was created for digital dissemination by the Medidata Patient Insights Diabetes Advocates Board.  The survey aimed to garner patient perspectives on all aspects of living with DPNP. The survey was shared across 36 independent patient advocacy partnerships and social media.

Results:

Two hundred fifty-three respondents took the survey and 38 were screened out.  Of the 215 respondents surveyed, 66.5% were female, 76.7% had T2D, 22.3% had T1D, and 96.3% had DPNP symptoms for greater than 1 year. The most commonly experienced DPNP symptoms were: (81.7%) pins/needles, (77.9%) tingling, (73.1%) burning pain, (58.1%) stabbing pain, (57.2%) electric-shock. DPNP symptoms significantly or severely impacted preforming normally daily activities and ability to continue to work in 39.9% and 44.2% of respondents, respectively.  DPNP significantly or severely impacted sleep in 30.7% and 12.5% of patients.  The majority of respondents (85%) reported use of an OTC pain reliever with 41.2% reporting daily use. Despite this OTC drug utilization, 43.5% reported OTC pain reliever efficacy as only somewhat effective and 42.9% reported not so effective. Many respondents (74.8%) reported use of pregabalin or gabapentin, with 72% reporting daily use. However, respondents reported its efficacy as somewhat effective (43.2%) and (22.6%) not so effective. Use of prescription opioid pain relievers to relieve DPNP symptoms was reported in 35.2 % of respondents. Daily or a few times a week frequency of prescription opioid pain reliever use was reported in 20.8% and 18.1%, respectively. Fifty percent of respondents reported the efficacy of a prescription opioid pain reliever as somewhat effective. While 29.2% reported the efficacy of a prescription opioid pain reliever as effective.

Conclusions/Implications for future research and/or clinical care:

The presented patient-level survey analysis demonstrates the vast unmet medical need and profound disease burden faced by patients living with DPNP. These DPNP symptoms negatively impacted normal daily activities, including the ability to work, and sleep in an overwhelmingly majority of respondents, despite the use of available OTC, prescription non-opioid, and opioid pain relievers. These survey results lend to the existing literature highlighting a critical gap in effective DPNP management. The insights from this patient survey will support the real-world patient needs in the design of the phase 3 pilavapadin clinical trial program.