Post-marketing and clinical safety experience with sodium oxybate for the treatment of alcohol withdrawal syndrome and maintenance of abstinence in alcohol-dependent subjects

ABSTRACT

Introduction: Sodium oxybate (SMO) has been approved in Italy and in Austria for the treatment of alcohol use disorder (AUD). This study describes the cumulative postmarketing and clinical safety experience with SMO in AUD.

Areas covered: Safety data for SMO at approved posology in AUD were identified from: (i) the clinical trial registries of the US National Institutes of Health (NIH) and the European Medicines Agency (EMA), (ii) reports from the biomedical literature and (iii) available pharmacovigilance safety information from the EMA.

Expert opinion: Safety data from 3 recent large randomized clinical studies (520 participants) and 43 earlier clinical studies (2547 participants) showed that SMO has a good safety profile in AUD patients. The safety profile was confirmed by pharmacovigilance data resulting from 299 013 patients exposed to SMO in Austria and Italy. Main adverse events were transitory dizziness and vertigo. Serious adverse events were rare. No death attributable to SMO has been reported. Risks of abuse or dependence are low in patients without psychiatric comorbidities or poly-drug use. The adverse events of SMO are transitory and do not require discontinuation of treatment. SMO abuse or dependence are extremely rare in patients without psychiatric comorbidities or poly-drug use.

KEYWORDS:

• Sodium oxybate
• alcohol use disorder
• safety
• pharmacovigilance
• post-marketing anaysis

Article highlights

• Safety data showed that SMO has a good safety profile in alcohol-dependent patients regardless of the DRL prior to treatment; such a good safety profile was confirmed by pharmacovigilance data for Alcover®.

• Adverse events are transitory and do not require discontinuation of treatment, and no side effects due to the combination of alcohol and SMO have been found in those patients who were still drinking during the treatment

• Very rare cases of SMO abuse and dependence may occur during treatment; patients with psychiatric comorbidities (particularly those with borderline personality disorder) or who are in remission from cocaine or heroin addiction have an increased risk of SMO abuse and caution is required when SMO therapy is contemplated in these patients (a controlled dispensing is required).

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Author contributions

G Addolorato and Q Raffaillac designed the analysis strategy. Literature search and data collection were performed by Q Raffaillac and F Caputo. G Addolorato, Q Raffaillac and F Caputo analyzed the data and wrote the first draft of the manuscript. Otto-Michael Lesch, Icro Maremmani, Henriette Walter and Felice Nava contributed to the analysis and interpretation of the data. All authors have approved the final manuscript.

Declaration of interest

G Addolorato served as a consultant for Ortho-McNeil Janssen Scientific Affairs, LLC, and D&A Pharma, and was paid for his consulting services. G Addolorato has received lecture fees from D&A Pharma. Q Raffaillac was employed by D&A Pharma, Paris, France until August 2019. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

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Additional information

Funding

This paper was not funded.