Analgesia is, in its simplest terms, an inability to feel pain. While analgesia and anesthesia are often grouped together, their functions are distinct. An analgesic (i.e., “painkiller”) is used to relieve existing pain, whereas an anesthetic is used to prevent pain. That being the case, there are some drugs that exhibit both analgesic and anesthetic properties.
Pain presents a number of unique challenges to drug developers and clinicians. First, pain as a sensation and as a symptom is difficult to quantify. There are no direct measurements for pain like there are to detect blood imbalances or vital sign abnormalities. Rather, pain is subjective and is most often measured using scales that rely upon how a patient perceives the intensity or severity of their pain. Pain can also be difficult to categorize. Typically, pain is broadly categorized according to how long it lasts.
To add to this complexity, analgesic drugs are a diverse class that can act on the peripheral and central nervous systems in a number of different ways. Aspirin and other nonsteroidal anti-inflammatory drugs, inhibit enzymes that are involved in the inflammatory response. Others, like opioids, bind receptors in the brain or elsewhere in the nervous system that are involved in sensing pain. Others operate by different mechanisms or by more than one mechanism. Given this diversity, pharmacotherapy encompasses molecules ranging from over-the-counter medications to Schedule 1 narcotics.
Because of significant pushback against opioid analgesics, which are effective pain relievers but also carry substantial risks of abuse and toxicity, there has been a recent push to develop alternative pain therapies. This has resulted in a creative array of new drug products using novel formulations of established drugs, as well as new molecular entities specific for novel targets.
There are many drug development and regulatory challenges for new analgesic therapies. Perhaps more than most other fields, successfully advancing new analgesic therapies through the development pipeline requires a sound clinical and regulatory strategy, careful clinical trial planning, and precise modeling to understand the variables consequential to the pharmacokinetics and pharmacodynamics (PK/PD) of the therapy.
Nuventra’s Analgesia Experience
Nuventra can perform any of our wide range of services for drugs to treat Analgesia indications. Some of our recent project experience in this area includes:
- Animal Rule Development Program Through Successful NDA Approval
- Clinical Pharmacology Studies (Protocols, Analysis & Reports)
- Data Management
- IND Authoring and Submission
- IND Sections
- Nonclinical PK/TK Studies (Protocols, Analysis & Reports)
- PK Analyses and Reporting
- Population PK Report
- Program Oversight & Project Planning
- Protocol Development for FTIH
- Regulatory Interactions with FDA
- Regulatory Writing and Submissions
- Strategic Advice
- Strategic Guidance to Address Clinical Hold
- Submission of Regulatory Documents
Visit our services page to see our full range of services and to learn more about what our drug development consultants can offer your program.
Nuventra has experience with a number of Analgesia indications, including:
- Breakthrough Cancer Pain
- Cyanide Poisoning
- Diabetic peripheral neuropathy
- Neuropathic Pain