title: A multicentre, open-label, follow-on study to assess the long-term maintenance of effect, tolerance and safety of THC/CBD oromucosal spray in the management of neuropathic pain.
abstract: Peripheral neuropathic pain (PNP) poses a significant clinical challenge. The long-term efficacy of delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray was investigated in this 38-week open-label extension study. In total, 380 patients with PNP associated with diabetes or allodynia entered this study from two parent randomised, controlled trials. Patients received THC/CBD spray for a further 38 weeks in addition to their current analgesic therapy. Neuropathic pain severity was the primary efficacy measure using a pain 0-10 numerical rating scale (NRS). Additional efficacy, safety and tolerability outcomes were also investigated. In total, 234 patients completed the study (62 %). The pain NRS showed a decrease in score over time in patients from a mean of 6.9 points (baseline in the parent studies) to a mean of 4.2 points (end of open-label follow-up). The proportion of patients who reported at least a clinically relevant 30 % improvement in pain continued to increase with time (up to 9 months); at least half of all patients reported a 30 % improvement at all time points. Improvements were observed for all secondary efficacy outcomes, including sleep quality 0-10 NRS scores, neuropathic pain scale scores, subject global impression of change and EQ-5D questionnaire scores. THC/CBD spray was well tolerated for the study duration and patients did not seek to increase their dose with time, with no new safety concerns arising from long-term use. In this previously difficult to manage patient population, THC/CBD spray was beneficial for the majority of patients with PNP associated with diabetes or allodynia.
authors.affiliation: Pain Management Research, Solihull Hospital, Solihull, UK, wallisb98@gmail.com.
authors.forename: B
authors.initials: B
authors.lastname: Hoggart
authors.forename: S
authors.initials: S
authors.lastname: Ratcliffe
authors.forename: E
authors.initials: E
authors.lastname: Ehler
authors.forename: K H
authors.initials: KH
authors.lastname: Simpson
authors.forename: J
authors.initials: J
authors.lastname: Hovorka
authors.forename: J
authors.initials: J
authors.lastname: Lejčko
authors.forename: L
authors.initials: L
authors.lastname: Taylor
authors.forename: H
authors.initials: H
authors.lastname: Lauder
authors.forename: M
authors.initials: M
authors.lastname: Serpell
mesh_terms: D000328:Adult; D000368:Aged; D000700:Analgesics / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D002185:Cannabidiol / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D003929:Diabetic Neuropathies / Q000150:complications; D013759:Dronabinol / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006930:Hyperalgesia / Q000150:complications; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000188:drug therapy* / Q000209:etiology; D058993:Oral Sprays; D059408:Pain Management; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D004338:Drug Combinations; D058993:Oral Sprays; D002185:Cannabidiol; D013759:Dronabinol