Buprenorphine + naloxone

Medicine Compliance Aid Stability · New Medicines ·
425741009

Medicine Compliance Aid Stability

Suboxone · Reckitt Benckiser Healthcare UK Ltd

Reckitt Benckiser Healthcare UK Ltd
Suboxone
Tablets sublingual 2mg/500 microgram, 8mg/2mg
R2 · Red 2 · Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Sublingual tablet, unsuitable for storage in MCA.
3rd March 2015

New Medicines

Zubsolv · Opioid dependence - fast dissolving sublingual tablet

Information

Zubsolv
New formulation
Orexo AB
Orexo AB

Development and Regulatory status

Licensed but not launched
Launched
Launched
Apr 20 · In its latest financial report, Orexo states that for the EU market, the ability to close collaborations with new potential partners will be dependent on the outcome of pricing discussions which are ongoing with authorities in multiple European countries. Orexo has continued to work intensively to establish a streamlined supply chain outside the US as low cost of goods will be essential in response to the increasing price pressure from generics characterising, foremost the EU market [10].
Dec 19 · Orexo is still looking for a commercial partner for the UK, planning to make available in the UK but cannot provide a timeline at present [9].
May 19 · Orexo is in advanced negotiations with multiple potential new partners who are interested in commercialising Zubsolv outside the US. In parallel, Orexo has taken full control of the supply chain and is working on an initiative that will bring down cost of goods sold significantly compared to the previous set-up. This will make the ex-US business case more attractive for both Orexo and its future partners [8].
Dec 18 · Orexo AB announces it will regain rights to Zubsolv for the treatment of opioid dependence in all territories outside the US from its current partner, Mundipharma, in Apr 19. Several potential partners have expressed interest in commercializing Zubsolv in specific regions and Orexo will now initiate formal negotiations with several interested parties [7].
Jun 18 · Launched in selected EU countries, including Germany and Sweden [6,7].
Nov 17 · Approved in EU [4].
Sep 17 · EU positive opinion for use as substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction [3].
Oct 16 · Filed in EU [1].
Jul 13 · Approved in US [1].

Category

Opioid-receptor partial agonist with an opioid antagonist
In December 2015, there were 150,907 clients registered in England for treatment for opiate use, 7.09% of those completing treatment and not re-presenting [2].
Opioid dependence - fast dissolving sublingual tablet
Sublingual

Trial or other data

Oct 18 · If approved, Zubsolv would be the first fast dissolving buprenorphine and naloxone product available in six unique strengths for treatment of opioid dependence in Europe [1]. The majority of commissioning is expected to be through Public Health England via addiction services.
Oct 16 · Similar to previous studies comparing Zubsolv to Suboxone US Tablet and film formulations, participants in a European study showed strong preference for Zubsolv. When compared with the Suboxone European tablet, Zubsolv was preferred by 77.0% (low dose) and 79.4% (high dose) of the subjects and the tablet dissolve times were faster for Zubsolv than for Suboxone [1].

Evidence based evaluations

Suboxone sublingual film · Opioid dependence, substitution treatment in adults and adolescents aged over 15 years - sublingual film

Information

Suboxone sublingual film
New formulation
Indivior
Indivior

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
Launched
Oct 20 · Launches in Canada, Germany, UK, Italy and the Nordics expected in H1 21 [8].
Jul 20 · Approved in EU [7].
Apr 20 · Recommended for EU approval by CHMP - the recommendation includes four strengths (2/0.5, 4/1, 8/2, and 16/4 mg) for either sublingual or buccal use, and the full indication is "Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Suboxone is indicated in adults and adolescents over 15 years of age who have agreed to be treated for addiction" [6]
Jun 19 · Indivior expects an approval from the EMA for buprenorphine/naloxone sublingual film in Q1 20 [5].
Mar 19 · Filed in EU [4].
Oct 18 · Indivior meet with the EMA and plan MAA submission in the EU for Mar 19 [3].
Sep 10 · Launched in the USA [3].

Category

Opioid partial agonist/antagonist - sublingual film formulation
In England in 2016/17, 279,793 adults presented to structured drug and alcohol services and of these, 52% were opioid users. 94% of patients received opioid substitution treatment, of whom a third were prescribed buprenorphine (about 80 per 100,000). In 2017, 35,517 prescriptions were dispensed for Suboxone sublingual tablets, a fixed-dose combination of buprenorphine/ naloxone already available (in 3 strengths), at a total cost of £1,109,581.
Opioid dependence, substitution treatment in adults and adolescents aged over 15 years - sublingual film
Sublingual

Trial or other data

Oct 08 · PII study (NCT00640835) completes [2].
Feb 08 · PII study to evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone starts (NCT00640835). 382 patients will be recruited in the US [1,2].

Evidence based evaluations