Buprenorphine implants: a model for expedited development and approval of new drugs

Guarnieri, Michael; Kedda, Jayanidhi; Tyler, Betty

doi:10.1080/03007995.2020.1840971

Cited by 1 publication

(3 citation statements)

References 60 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Studies have demonstrated virtually identical MOR receptor-binding properties in animals and humans [ 58 ]. Buprenorphine’s receptor- binding characteristics provide both a necessary and sufficient explanation for the drug’s analgesic and opioid use deterrence properties [ 19 , 59 ].…”

Section: Discussionmentioning

confidence: 99%

“…A range of studies has demonstrated the analgesic biosimilarity of LAI opioids to multiple bolus doses of the legacy drug [ 13 , 14 , 15 , 16 , 17 , 18 ]. Investigators further evaluated analgesia by demonstrating the bioequivalence of buprenorphine in LAI formats and the generic drug given in single or multiple injections [ 19 ]. Drugs are confirmed to be bioequivalent if they enter the circulation and are accessible to the drug’s receptor at the same rates [ 20 ].…”

Section: Introductionmentioning

confidence: 99%

“…The kinetics of the drug in circulation are key determinants of its bioavailability. Bioavailability data can substitute for new rounds of efficacy trials, thereby decreasing both the time to approval as well as reducing the costs required for new studies [ 19 ].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Long-Acting Opioid Analgesics for Acute Pain: Pharmacokinetic Evidence Reviewed

Tyler

Guarnieri

2023

Veterinary Sciences

Self Cite

View full text Add to dashboard Cite

Long-acting injectable (LAI) opioid formulations mitigate the harm profiles and management challenges associated with providing effective analgesia for animals. A single dose of a long-acting opioid analgesic can provide up to 72 h of clinically relevant pain management. Yet, few of these new drugs have been translated to products for veterinary clinics. Regulatory pathways allow accelerated drug approvals for generic and biosimilar drugs. These pathways depend on rigorous evidence for drug safety and pharmacokinetic evidence demonstrating bioequivalence between the new and the legacy drug. This report reviews the animal PK data associated with lipid and polymer-bound buprenorphine LAI formulations. Buprenorphine is a widely used veterinary opioid analgesic. Because of its safety profile and regulatory status, buprenorphine is more accessible than morphine, methadone, and fentanyl. This review of PK studies coupled with the well-established safety profile of buprenorphine suggests that the accelerated approval pathways may be available for this new family of LAI veterinary pharmaceuticals.

show abstract

Section: Discussionmentioning

confidence: 99%