Regulatory Decision Summary for Odan-Pregabalin

The purpose of this New Drug Submission was to obtain market authorization, pursuant to section C.08.004 of the Food and Drug Regulations, for Odan-Pregabalin (pregabalin oral solution, 20 milligrams per millilitre), filed by Odan Laboratories Ltd.

Upon review of the submitted data package, Health Canada authorized Odan-Pregabalin as filed for the following indication: management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and spinal cord injury, and for the management of pain associated with fibromyalgia.

The efficacy and safety of pregabalin for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and spinal cord injury, and for the management of pain associated with fibromyalgia have been previously demonstrated through the authorization of Lyrica (pregabalin capsules). In Europe and in the United States, Lyrica has also been available as an oral solution for more than fifteen years.

As the indications and dosing recommendations proposed for Odan-Pregabalin are identical to those currently approved for Lyrica, the aim of this New Drug Submission was to demonstrate comparable bioavailability of the proposed Odan-Pregabalin oral solution relative to the Lyrica capsules, and to confirm that the change in formulation does not alter the established benefit-harm-uncertainty profile of pregabalin when used for the approved indications.

The Division of Biopharmaceutics Evaluation from the Bureau of Pharmaceutical Sciences confirmed that Odan-Pregabalin demonstrated to be bioequivalent to the reference product Lyrica. It was concluded that a milligram-per-milligram interchangeability was appropriate between Odan-Pregabalin oral solution and Lyrica capsules.

Study C1B03015 assessed the comparative bioavailability between Odan-Pregabalin Oral Solution, 20 milligrams per millilitre (mg/mL), (Dose = 300 mg/15 mL) and Lyrica capsules, 300 mg, in healthy adult male subjects under fasting conditions. The study was well designed and conducted, and the results met the comparative bioavailability standards of Health Canada.

The chemistry and manufacturing information submitted for Odan-Pregabalin met Health Canada requirements, and there were no significant quality concerns related to the proposed formulation.

The Product Monograph is consistent with the Lyrica Product Monograph, except for formulation-related inclusions made in sections 4 Dosage and Administration and section 10.3 Pharmacokinetics. The final labelling and Product Monograph were considered acceptable.

Overall, the benefit-harm-uncertainty profile was favourable for Odan-Pregabalin for the approved indications when used under the conditions recommended in the approved Product Monograph. A Notice of Compliance was recommended.

For further details about Odan-Pregabalin, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.