Research Articles, page-2

http://www.futuremedicine.com/doi/pdf/10.2217/pmt-2016-0068

Pharmacokinetics, safety and tolerability of a novel tocopheryl phosphate mixture/oxycodone transdermal patch system: a Phase I study
Paul D Gavin*mce-anchor^,1mce-anchor, Lee S Simonmce-anchor²mce-anchor, Thomas Schlagheckmce-anchor³mce-anchor, Alisha J Smithmce-anchor¹mce-anchor & Sepehr Shakibmce-anchor⁴mce-anchor

*Author for correspondence: [email protected]

Aim: To characterize the pharmacokinetic profile and evaluate the safety and tolerability of a transdermal oxycodone patch containing tocopheryl phosphate mixture (TPM). Patients & methods: Eleven healthy subjects received a single application of three TPM/oxycodone patches applied to the torso for 72 h. Results: Oxycodone was detected 8.0 ± 2.7-h postpatch administration, reaching a mean maximum plasma concentration of 3.41 ± 1.34 ng/ml at 49.3 ± 21.2 h. The safety profile was consistent with the application method and known side-effect profile of oxycodone and naltrexone. No treatment-limiting skin irritation was observed. Conclusion: A 3-day application of the TPM/oxycodone patch demonstrated an acceptable safety profile and was well tolerated by healthy subjects, with limited dermal irritation following application.








http://www.futuremedicine.com/doi/pdf/10.2217/pmt-2016-0067

Transdermal oxycodone patch for the treatment of postherpetic neuralgia: a randomized, double-blind, controlled trial
Paul D Gavin*mce-anchor^,1mce-anchor, Louise Trempermce-anchor¹mce-anchor, Alisha Smithmce-anchor¹mce-anchor, Gemma Williamsmce-anchor²mce-anchor & Charles Brookermce-anchor³mce-anchor
*Author for correspondence: [email protected]

Aim: To evaluate the efficacy, systemic exposure, safety and tolerability of a transdermal oxycodone patch containing tocopheryl phosphate mixture (TPM) in patients with postherpetic neuralgia (PHN). Patients & methods: The study was a Phase IIa, multicenter, randomized, double-blind, vehicle-controlled crossover study. Results: While the TPM/oxycodone patch did not significantly improve ‘average’ Numeric Pain Rating Scale scores versus vehicle patch, patients reporting high levels of paresthesia (n = 9) showed a trend toward improved pain reduction. The TPM/oxycodone patch resulted in a low systemic exposure to oxycodone and was well tolerated. Conclusion: The TPM/oxycodone patch delivered oxycodone to the site of perceived pain in subjects suffering from PHN, but did not provide analgesia for the broad PHN indication.