Novel Pain Model Development

CRI Lifetree is in the forefront of leveraging experimental pain models in healthy volunteers to demonstrate efficacy early in the drug development process. The cold pressor, a model of acute pain, is robustly sensitive to the analgesic activity of opiates (Koltzenburg et al., 2006; Escher et al., 2007) whereas contradicting results are observed with NSAIDs (Jones et al., 1988; Compton et al., 2003). A combination of heat plus capsaicin, induces a type of cutaneous sensitization that models neuropathic pain conditions such as post-herpetic neuralgia and diabetic peripheral neuropathy (Dirks et al., 2003). Heat/capsaicin-induced hyperalgesia and allodynia are sensitive to opioids, local anesthetics, and antiepileptic drugs such as gabapentin and pregabalin (Dirks et al., 2000; Petersen et al., 2001; Dirks et al., 2002; Gottrup et al., 2004; Wang et al., 2008). Quantitative sensory testing (QST) is carried out utilizing a Neurometer® which allows CRI Lifetree physicians and staff to explore different pain modalities transmitted by distinct populations of nerve fibers (Sakai et al., 2006).

CRI Lifetree Salt Lake City staff contributed in pioneering the development of the post-operative bunionectomy acute pain model and the associated methodology that has been presented to the FDA and is now widely used in the analgesic drug development process.

CRI Lifetree Salt Lake City is the leading site in the US for human pain model development. The Scientific Leadership in Salt Lake City is Miroslav "Misha” Backonja, MD and Lynn Webster, MD. Together with the strong clinical team in Salt Lake, we have conducted 8 studies using these models. Our physicians have deep collaborative relationships with Neuropathic Pain Research Consortium. Our expertise includes the following models:

• UVB burn (UVB)
• Intra-dermal (ID) capsaicin and Cold pressor test (CPT)

• UVB burn (UVB) - peripheral
• Intra-dermal (ID) capsaicin – peripheral and central
• Cold pressor test (CPT) - central

• Whether NCE has any analgesic properties
• Dose-range finding
• Whether NCE is peripherally or centrally acting with implication to inform which clinical pain disease models to proceed with in later phases
• Most appropriate outcome measures to carry into later phases

CRI Lifetree understands the ever changing drug development market and the need for novel pain model development and progress. CRI Lifetree Salt Lake City is uniquely qualified to offer cutting edge technology and methodologies to provide you with innovative clinical trial models.