Expert review of clinical pharmacology
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Expert Rev Clin Pharmacol · Jan 2015
EditorialPrediction of treatment outcomes in major depressive disorder.
Improving the treatment of major depressive disorder will require identification of moderators that predict differential outcomes across treatments at the level of the individual patient, referred to as precision medicine. Currently, there are no biological measures demonstrated to enhance treatment selection accuracy although there are some clinical variables that have prognostic value. ⋯ Genetic combination tests, systemic inflammation, electroencephalography and neuroimaging, in particular, show significant potential for near-term development as clinically meaningful moderators for use in treatment selection. Ultimately, combinations of moderators may provide the greatest level of precision in selecting optimal treatment approaches for individual depressed patients.
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Expert Rev Clin Pharmacol · Jan 2015
ReviewFentanyl buccal tablet for the treatment of cancer-related breakthrough pain.
Fentanyl buccal tablet (FBT) (FENTORA) is indicated for the management of breakthrough pain (BTP) in patients with cancer pain and who are tolerant to ≥60 mg of oral morphine equivalents, at least with the current availability of the minimal strength of 100 μg. FBT uses the OraVescent technology to further increase the rate and extent of absorption of fentanyl. ⋯ It has been recommended that administration should be tailored to the patient's individual requirement, through dose titration starting from the lowest dose to find the effective dose. However, recent studies have demonstrated that predictable doses calculated from the basal opioid regimen are safe and more effective than doses achieved after dose titration.
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Expert Rev Clin Pharmacol · Jan 2015
ReviewUsing real-world healthcare data for pharmacovigilance signal detection - the experience of the EU-ADR project.
A prospective pharmacovigilance signal detection study, comparing the real-world healthcare data (EU-ADR) and two spontaneous reporting system (SRS) databases, US FDA's Adverse Event Reporting System and WHO's Vigibase is reported. The study compared drug safety signals found in the EU-ADR and SRS databases. ⋯ The EU-ADR system may have a greater potential for detecting signals for events occurring at higher frequency in general population and those that are commonly not considered as potentially a drug-induced event. Factors influencing various differences between the datasets are discussed along with potential limitations and applications to pharmacovigilance practice.
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Expert Rev Clin Pharmacol · Jan 2015
ReviewDabrafenib in combination with trametinib for the treatment of metastatic melanoma.
Oncogenic BRAF mutations are present in approximately 40-50% of patients with metastatic melanoma. Targeting BRAF mutations with either small molecule inhibitors of BRAF or one of the downstream mediators of oncogenic BRAF - MEK - is associated with improved outcomes compared with chemotherapy and has led to the US FDA approval of two BRAF inhibitors - vemurafenib and dabrafenib - and the MEK inhibitor trametinib. Further, the combination of dabrafenib and trametinib is well tolerated and associated with higher responses and improved survival compared with single-agent BRAF inhibitors.
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In the EU, the EMA has been working with biosimilars since 1998. This experience is crystallized in the extensive set of guidelines, which range from basic principles to details of clinical trials. While the guidance may appear complicated, it has enabled the development of biosimilars, of which 21 have managed to get marketing authorization. ⋯ The most controversial issues with biosimilars are immunogenicity and extrapolation of therapeutic indications. The available data for these topics do not raise concerns among EU regulators. Interchangeability and substitution are regulated by individual EU member states.