Submit in vitro data on safety of Ropivacaine HCL monohydrate delivery: CDSCO panel tells Cipla
New Delhi: In line with the pharma major Cipla's Phase III clinical trial data for the local anaesthetic drug Ropivacaine HCL monohydrate solution for infusion 2 mg/ml, the Subject Expert Committee functioning under the Central Drug Standard Control Organization (CDSCO) has opined the firm to submit the in-vitro data on the safety of the drug delivery Ropivacaine Readyfusor device in comparison with the other/existing delivery systems.
This came after the drug-maker Cipla presented the report of the Phase 3 Clinical Trial of the Ropivacaine HCL monohydrate solution for infusion at 2 mg/ml before the committee.
Ropivacaine Readyfusor is a device containing ropivacaine hydrochloride, a local anaesthetic that is already present in the dispenser. The local anaesthetic is administered into the body, preventing nerves from transmitting messages to the brain. Depending on the dosage, it will either totally eradicate pain or produce a partial loss of sensation. After surgery, the Ropivacaine Readyfusor is used to relieve post-operative pain in adults.
Ropivacaine HCL is a prescription medicine used as an anaesthetic during surgery or to ease labour pains. Ropivacaine HCL may be used alone or with other medications.
Ropivacaine blocks the generation and conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential.
Specifically, Ropivacaine blocks the sodium-channel and decreases the chances of depolarization and consequent action potentials. In general, the progression of anaesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers.
Earlier, the Medical Dialogues Team had reported that drug major Cipla had inked a pact with US-based BioQ Pharma for registration and commercialisation of BioQ Pharma's Ropivacaine infusion system, used in treating post-operative pain, in India.
At the recent SEC meeting for analgesics and rheumatology dated 10.02.2022, the committee extensively reviewed the report of the Phase 3 Clinical Trial of the Ropivacaine HCL monohydrate solution for infusion at 2 mg/ml.
After detailed deliberation, the committee recommended that the firm submit the in-vitro data on the safety of drug delivery through the Ropivacaine Readyfusor device in comparison with the other/existing delivery systems.
In addition, the committee also directed the firm to submit the updated package insert with the warning/handling on the use of the device as mentioned in the package insert of the product marketed internationally.
