Analgesic Drug Development
Validated Pain Models for Early-Phase Trials
Altasciences has over two decades of experience in analgesic drug development and pain modeling, including physical dependency and abuse potential assessments. Our highly skilled pain experts and neuroscientists assist you in selecting the most appropriate pain models to successfully evaluate the efficacy and safety profile of your study drug.
Consult our Pain Model Fact Sheet
WEBINAR―Explore the flexible selection of pharmacodynamic measures to enhance the pharmacology, safety, and efficacy evaluation of CNS-active drugs in early clinical trials.
How We Help Advance Your Pain Therapeutic
Pain models serve as a useful tool to model various types of pain, such as nociceptive and neuropathic. Altasciences uses such models in early-phase research, translating the models from preclinical assessment to clinical testing to characterize a dose-response relationship for a novel analgesic.
At Altasciences, pain models for analgesic drug development are typically conducted in normal healthy participants but can also be assessed in pain patients. Identifying the appropriate model for your novel analgesic is a critical first step. Successful designs require careful consideration of reproducibility, consistency, use of baseline measures and controls. Pain modeling uses various types of stimulation, including mechanical, thermal, chemical, and electric, each with distinct endpoints, mechanisms of action, and responsiveness to analgesic drug classes.
Altasciences is experienced with, and conducts studies in, different pain models, including:
- Cold Pressor Test
- Von Frey (manual and electronic)
- Thermal Probes
- UVB
- Capsaicin
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Barostat Method
- Staircase Challenge
Biomarkers may also be included to further characterize your compound. We can assist in determining the best approaches depending on the mechanism of action of your analgesic.
Standardization of Methods
Our successful implementation and execution of pain models depends on strict attention to operating procedures to ensure the reproducibility and consistency of results. Our standardized methods, based on best practices, are critical to reducing variability between tests and study participants. We test and validate all methods to deliver consistent stimuli and ensure they operate within a safe capacity for participants.
We align our operating procedures with published and validated research models. We maintain a robust training program for both staff and participants to ensure consistent application and reduce variability.
Integrated Service Offering for Analgesic Drug Development
In addition to pain models, our team of experts will guide you across the many unique opportunities and challenges in analgesic research. If your program requires expertise in any early-phase analgesic drug development service, we can help you navigate
- Proof of concept
- First-in-human—single and multiple ascending dose
- Opioid blockade (antagonist)
- Drug-drug interaction
- Abuse and/or dependency assessment
- Pharmacokinetic (PK)/Pharmacodynamic (PD) evaluation
- Phase II dose-ranging studies of safety and efficacy
- Regulatory support and strategic planning for this potentially complex therapeutic area
We support your analgesic drug development with complex and adaptive study designs, including enrichment phases to control for variability in outcome measures. To complement our in-house expertise, we partner with Cambridge Cognition and Medoc Advanced Medical Systems, two organizations renowned in the field of CNS testing. We also collaborate with a highly experienced knee surgeon for study setup and endpoint evaluation.
We offer expert project management for multi-site trials, including training sites on recruitment and/or pain models to achieve high inter-rater agreement.
Accelerated Start-up Timelines for Analgesic Drug Development
We get your study started quickly and efficiently— in as little as four weeks. We facilitate prompt decision-making and rapid issue resolution with effective communication, strategic planning, and a dual project management structure, ensuring seamless alignment between our internal teams and you, the sponsor.
Altasciences’ clinics, located in both Canada and the US, give additional flexibility to benefit from efficiency, regulatory advantages, and tax credits. Our global regulatory expertise is at your disposal, to help plan and deliver the most appropriate program for your needs. We provide dual regulatory pathway options—Investigational New Drug (IND) and Clinical Trial Application (CTA).
Rapid and Efficient Recruitment for Analgesic Drug Development
Recruiting and retaining participants for pain model studies involves thorough screening and selection, comprehensive training on the completion of pharmacodynamic assessments, and provision of a safe and comfortable environment. At Altasciences, we engage, train, and retain, to ensure that healthy normal participants have the necessary understanding of trial procedures. Planning for these activities is critical to deliver and retain full panels, which supports timely study conduct and robust data collection.
If pain patients are required for your study, we have access to a network of hospitals and clinics to successfully recruit full patient panels.
Turnkey Solutions for Analgesic Drug Development
We offer a turnkey solution for pain studies in healthy normal volunteers, handling every aspect of your trial from start to finish.
Protocol review/writing:
Whether starting from scratch or refining an existing protocol, our team of clinical experts will ensure we streamline the process to support informed decision-making and meet your critical study milestones. With our deep understanding of DDI studies and early-phase clinical trials, we ensure comprehensive, regulatory-compliant study design. We tailor protocols to meet the specific requirements of custom drug-interaction studies, focusing on efficient timelines and precise data collection.
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Clinical conduct:
Our three state-of-the-art clinics across North America are fully equipped to run your analgesic drug development study, with expert teams managing dosing, sampling, and pain model applications.
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CRA/Clinical monitoring:
Real-time tracking of PK/PD data, safety assessments, and adverse event reporting ensures compliance with regulatory requirements and maintains data integrity throughout your trial.
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Bioanalytical services:
Our state-of-the-art, co-located bioanalytical labs are equipped with a wide range of assays, ensuring precise and timely PK data, biomarkers of inflammation, and other endpoints as appropriate. We also have expertise in flow cytometry for your analgesic drug development. Leveraging these established methods, we provide the reliable data you need to meet regulatory standards, enabling faster decision-making and providing comprehensive label information.
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Consult our Validated Assay List
Data Services and Reporting:
We handle data management, analysis, and comprehensive reporting to deliver timely, high-quality results to satisfy stringent regulatory requirements.
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Regulatory Consulting:
Need support navigating regulatory requirements? Our experts can assist with a detailed plan for your preliminary pain studies.
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At Altasciences, we ensure your analgesic drug study is fully enrolled, expertly conducted, and delivers accurate data on time.
Altasciences’ Analgesic Drug Development Case Studies and Resources
FAQ
What Pain Models Does Altasciences Have for Analgesic Drug Development?
Early-phase pain models involve using heat-induced pain and sensitivity in healthy normal volunteers during early-phase analgesic drug development.
Cold Pressor Test
The cold pressor test measures pain tolerance and cardiovascular effects when a hand is submerged in cold water.
Cutaneous Freeze Injury
The cutaneous freeze injury pain model Involves the application of cold temperatures at a standardized pressure and provides stable testing conditions lasting about a day.
UVB Hyperalgesia
The UVB hyperalgesia model uses irradiation with ultraviolet B light, causing injury and an inflammatory response similar to sunburn.
Thermal Probe
The thermal probe test quantifies thermal thresholds by measuring the temperature at which withdrawal occurs.
Capsaicin
Capsaicin is an alkaloid found in hot peppers, which induces intense burning sensations, applied topically or via intra-dermal injection representing central sensitization.
Transcutaneous Electrical Nerve Stimulation (TENS)
TENS uses an electrical stimulator that delivers stimulation patterns with different frequencies, durations, and waveforms.
Barostat Model (for Visceral Pain)
The barostat model induces pain via distention of the viscera using a polyethylene balloon delivered by intubation of the esophagus.
Von Frey (Manual/Electric)
The Von Frey method is a mechanical stimulation model that applies light pressure to assess sensitivity to touch.
Staircase Challenge
In the staircase challenge, participants fully step on an eight-inch (20 cm) high platform with one foot then the other, and back down, to evoke pain by exercise, with delayed-onset muscle soreness.
Skin Punch
The skin punch pain model is frequently used for biopsies to diagnose various skin and hair conditions. It can also be used to assess pain and wound healing in clinical trials of pain interventions.
How do abuse potential and physical dependency assessments factor into pain drug trials?
Abuse potential and physical dependency assessments are critical components of analgesic drug development, particularly for drugs that act on the central nervous system (CNS), such as opioids and other analgesics with potential for misuse. We conduct these assessments to ensure regulatory compliance, mitigate risks, and guide appropriate labeling and prescribing recommendations.
Regulatory agencies such as the FDA, EMA, and Health Canada require a comprehensive abuse potential assessment as part of the New Drug Application (NDA) for CNS-active drugs.
This includes:
- Human abuse potential study data, which evaluates the likelihood that the drug could be misused or abused
- Post-marketing risk evaluation and mitigation strategies (REMS), if necessary
- Controlled substance scheduling recommendations (e.g., Schedule II or III under the U.S. Controlled Substances Act)
How do translational models bridge preclinical and early-phase clinical research as regards abuse potential and dependence?
First, abuse potential is evaluated through animal studies using models like:
- Self-administration tests to determine if animals voluntarily consume the drug.
- Drug discrimination tests to see if the drug produces effects similar to known drugs of abuse.
- Physical dependence models: To assess withdrawal symptoms upon cessation.
Then, early clinical trials often include human abuse potential (HAP) studies, where the new drug is compared with a placebo and a known drug of abuse in recreational drug users to assess subjective effects (e.g., euphoria, drug liking). Pharmacokinetic (PK) and pharmacodynamic (PD) profiles are analyzed to determine abuse liability.
What are the advantages of conducting early-phase analgesic trials in healthy participants?
Early-phase analgesic trials in healthy participants offer several advantages in evaluating a drug’s safety, PK/PD, and preliminary efficacy before testing in patients with chronic pain conditions. These benefits include:
- Controlled environment for safety and PK
- Minimizes confounding factors since Healthy participants lack underlying pain conditions or comorbidities, reducing variability in drug response.
- More reliable PK data, as drug absorption, metabolism, and excretion can be assessed without disease-related alterations.
- Early safety signals: Adverse effects can be identified before testing in vulnerable patient populations.
- Use of experimental pain models for early efficacy signals
- Mechanism-based evaluation helps determine if a drug targets specific pain pathways (e.g., neuropathic, inflammatory, nociceptive pain).
- Efficient, early proof-of-concept testing demonstrates whether the drug modulates pain perception before investing in larger patient trials.
- Faster and more cost-effective development
- Shorter trial duration, as healthy participant studies are typically shorter than patient trials.
- Early Go/No-Go decisions: If the drug presents issues in healthy models, resources can be redirected before costly patient trials.