Zubsolv(buprenorphine/naloxone)

Psychiatry· 63 cited findings· 1 source document

Company: Accord S L U

What the regulatory reviews say

Zubsolv (buprenorphine/naloxone) is indicated for opioid dependence. Efficacy findings include retention in treatment rates of 83.0%, 82.5%, 93.9%, 92.6%, 88.3%, and 95.3%. When compared to Suboxone, the difference in retention in treatment was 0.5%. Compared to buprenorphine, the difference in retention in treatment was 1.3%, while compared to generic buprenorphine, the difference was -7.0%. Buprenorphine exposure (AUC0-72h and Cmax) had a GMR 90% CI vs Suboxone of 80% to 125%, with buprenorphine exposure being approximately 20% lower and naloxone exposure approximately 35% lower than Suboxone.

Notable safety findings in healthy subjects included nausea (23.0%), dizziness (11.2%), vomiting (10.6%), and headache (10.4%). The percentage of patients with treatment-emergent adverse events (TEAEs) in the System Organ Class (SOC) of infections and infestations was 10.3% for Zubsolv, compared to 6.7% for the reference. Insomnia was reported in 2.6% of the Zubsolv group versus 7.1% in the generic buprenorphine group. The total Zubsolv patient-years exposure was 44,800 patient-years.

Regulatory milestones include a marketing authorisation application submission date of 3 October 2016 and a CHMP positive opinion date of 14 September 2017. The US market approval date was July 3rd, 2013. The shelf life for Zubsolv was reported as 2 years, 4 years, and 30 months.

Key figures — cited to the source page

Retention in treatment (difference vs Suboxone)	0.5%	Accord S L U — Zubsolv EMA EPAR public assessment report (EM, p.32
Retention in treatment (difference vs buprenorphine)	1.3%	Accord S L U — Zubsolv EMA EPAR public assessment report (EM, p.32
Retention in treatment (difference vs generic buprenorphine)	-7.0%	Accord S L U — Zubsolv EMA EPAR public assessment report (EM, p.32
Nausea in healthy subjects	23.0%	Accord S L U — Zubsolv EMA EPAR public assessment report (EM, p.35
Insomnia in Zubsolv group	2.6%	Accord S L U — Zubsolv EMA EPAR public assessment report (EM, p.36
Insomnia in generic buprenorphine group	7.1%	Accord S L U — Zubsolv EMA EPAR public assessment report (EM, p.36
US market approval date	July 3rd 2013	Accord S L U — Zubsolv EMA EPAR public assessment report (EM, p.37
CHMP positive opinion date	14 September 2017	Accord S L U — Zubsolv EMA EPAR public assessment report (EM, p.8

Source documents

Accord S L U — Zubsolv EMA EPAR public assessment report (EMEA/H/C/004407, 2017) (2017)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.