One of the leading health conditions facing today’s society is acute pain. This type of pain can result from most any situation including sprains and strains, all the way to trauma requiring surgery in the outpatient and hospital settings.
Charleston’s lead drug in its pipeline of acute pain treatments, CL-108, is in development for pain that requires an opioid analgesic, while preventing or reducing Opioid-Induced Nausea and Vomiting (OINV).
A novel bi-layered tablet with a bi-phasic release of 12.5 mg of rapid release promethazine with a modified release of 7.5 mg of hydrocodone and 325 mg of acetaminophen, CL-108 is being developed for patients who suffer from moderate-to-severe acute pain while preventing Opioid-Induced Nausea and Vomiting (OINV).
A novel formulation containing rapid release promethazine with a modified release of oxycodone, CLOX-315 is being investigated for treatment of pain requiring the use of opioid therapy, and the prevention or reduction of OINV.
A novel C-III formulation containing rapid release promethazine with a modified release of tramadol, CLP-417 is being investigated for treatment of moderate-to-severe pain and the reduction or elimination of opioid-induced nausea and vomiting (OINV).
A novel C-II formulation containing rapid release promethazine with a modified release of hydromorphone, CLP-517 is being investigated for the treatment of severe pain requiring opioid analgesic and the prevention or reduction of opioid-induced nausea and vomiting.
Pre-Clinical research takes place before any human testing is done using animals to find out if a drug, procedure, or treatment is likely to be useful.
Phase 1 clinical trials are classified as early stage studies for up to 1 month in duration on 20-80 healthy volunteers to evaluate the safety, appropriate dose range, toxicity limits, and side effects of a new drug or treatment.
Phase 2 clinical trials are classified as late stage studies on 200 to 300 individuals for up to several months’ duration on patients with a specific targeted disease to further evaluate the safety, effectiveness, and short-term side effects of the new drug.
Phase 3 clinical trials are classified as final stage studies on hundreds to thousands of patients that can last several years to confirm safety and effectiveness compared to commonly used products, monitor side effects and obtain further data on secondary endpoints that will help the new drug be used safely.
The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.