Korea United Pharm is seeking to expand the indication of Clanza CR (ingredient: aceclofenac), an incrementally modified drug (IMD) for pain relief in various diseases.
On Tuesday, the company said it had started a clinical trial of Clanza CR to add an indication for “post-traumatic pain.”
Approved indications for Clanza CR include rheumatoid arthritis, ankylosing spondylitis, osteoarthritis (degenerative arthritis), periarthritis of the scapulo-humidis, low back pain, sciatica, pain caused by non-articular rheumatism.
On Friday, Korea United Pharm got the regulatory green light to conduct a phase 3 trial of UI074, a codename of Clanza CR. The study will be randomized, double-blind, placebo-controlled, parallel design and conducted at Chung-Ang University Hospital.
The company obtained marketing authorization for Clanza CR as an IMD in 2010. Patients can only take one tablet of Clanza CR, a nonsteroidal anti-inflammatory drug (NSAID), once a day.
However, sales of Clanza CR have been poor in recent years compared to other NSAIDs. Data from UBIST shows that outpatient prescriptions for Clanza CR have not exceeded 1 billion won ($810,389) per year since 2018.
Observers said Korea United Pharm’s decision to extend Clanza CR’s indication was aimed at boosting sales of the drug.
Korean pharmaceutical companies have recently begun to expand the scope of NSAID indications for osteoarthritis.
In 2020, Daewon Pharmaceutical added post-traumatic pain to the indication for Pelubi SR (pelubiprofen), an NSAID.
The additional indication for Clanza CR will depend on Korea United Pharm’s ability to prove the drug’s immediate analgesic effect in the Phase 3 trial, observers said.
If Clanza CR gets an additional indication for post-traumatic pain, it will be prescribed for muscle strains, sprains and other soft tissue disorders.
The question of whether Korea United Pharm will obtain the additional indication and increase the prescription sales of Clanza CR attracts attention.