New buprenorphine wafers could help thousands battling opioid addiction

When compared with current hard sublingual tablets, the novel formulation dissolved quickly with no increased safety concerns and no demonstrable difference in efficacy.

“Buprenorphine plays a vital role in opioid substitution therapy for many patients. However, it is recognised that a significant barrier has been the time-consuming and often stigmatising process of supervising its administration,” said Dr Baillie, Group Medical Director of Martindale Pharma. “These data demonstrate that using this rapidly-dissolving formulation of buprenorphine may offer practical benefits without compromising safety or efficacy.”

The study assessed the safety of the new buprenorphine oral lyophilisate wafer versus standard sublingual buprenorphine tablets, (Subutex). Patients were opioid-dependent, commencing buprenorphine maintenance and were treated in a specialised clinical trials or addictions treatment facility. Results showed that 96.3% of Espranor administrations achieved partial disintegration on the tongue within 15 seconds, meaning at this time point the wafer could no longer be removed from the mouth intact. Overall the median time to complete disintegration of the Espranor wafer was two minutes compared with 10 minutes for standard sublingual buprenorphine tablets (p< 0.0001). There were no significant between-group differences in opiate-withdrawal phenomena, craving or adequacy of “hold,” or respiratory function. No serious adverse events (AEs) were observed. Although more mild AEs and treatment-emergent AEs were observed with the wafer formulation, all events were transient and self-limiting. Pharmacokinetic analysis found greater bioavailability of buprenorphine but not nor-buprenorphine with Espranor.

“It is vital that we find better ways of supporting people across the UK battling opioid addiction,” said Annemarie Ward, CEO of Faces and Voices of Recovery. “These results are promising as they indicate that, by just using a simpler form of buprenorphine, we may increase its use and reduce some of the problems seen with conventional pills. Having another choice of treatment available is always a cause for celebration. The challenge now will be to explore how we help those on the front lines of OST understand how and when it should be used.”