Anesthesia broadly means a loss of sensation. Typically, anesthetics are used to prevent pain and other undesirable sensations. This function is distinct from that of analgesics, which are used to relieve pain, although certain anesthetics can exhibit analgesic properties.

Anesthetics can be divided into three main classes: general anesthetics, sedatives, and local anesthetics. Because of their varied uses, routes of administration, and modes of action, developing anesthesia drugs can be challenging.

General anesthetics consist primarily of inhaled gasses and intravenous liquids. These products are typically used prior to surgical procedures to temporarily and reversibly render a patient completely unconscious. While new molecular entities in anesthesia have been uncommon for many years, generic alternatives continue to come onto the market.

Sedatives are typically injectable liquids or oral formulations that can be used for a number of purposes, including to induce sleep, treat anxiety, promote muscle relaxation, or treat convulsions. Unlike general anesthetics, sedatives do not result in full unconsciousness under normal usage, but rather they evoke a state of decreased awareness where the patient typically retains the ability to respond to stimuli.

Local anesthetics are usually injected into the tissue or applied topically, often as a cream, gel, ointment, or patch. Many local anesthetics are also referred to as numbing agents and are frequently used to prevent pain associated with certain dental and dermatological procedures. In these contexts, local anesthetics may be used along with epinephrine (or a derivative), which acts as a vasoconstrictor to reduce bleeding. Local anesthetics can also be injected around larger nerves and even around the spinal cord itself to provide regional anesthesia (e.g., peripheral nerve block, epidural anesthesia).

Nuventra’s Anesthesia Experience

Nuventra can perform any of our wide range of services for any type of Anesthesia drug program. Some of our relevant project experience in this area includes:

• 505(b)(2)
• Animal Rule Development
• Clinical and Nonclinical Protocol Development (including FTIH studies)
• Clinical Pharmacology Development Plan
• Clinical PK Analysis and Reporting
• Clinical Study Design
• Data Management
• Design, Execution and Reporting of Preclinical Studies
• Due Dilligence
• Evaluating Drug Delivery System
• Interactions with Regulatory Authorities
• Nonclinical PK/TK Analysis and Reporting
• Outlining Challenges for Approval Process
• Pharmacology and Safety
• Population PK Analysis and Reporting
• Regulatory Writing and Submissions (IND, NDA)
• Strategic Advice (Study Level to Program Level)

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.

Anesthesia Indications

Nuventra has experience with a number of Anesthesia indications, including:

• Concomitant Use of Anesthetics with Cardiovascular Agents
• General Anesthetics (Injectable and Volatile)
• Local Anesthetics
• Neuromuscular Blockers
• Neuromuscular Blocking Agents
• Novel Drug Delivery Systems
• Sedatives