China Aoxing Wins Approval for OTC Pain Drug

China Aoxing Pharmaceutical Company (CAXG.OB) was awarded an SFDA production license for Paracetamol (acetaminophen) and Caffeine Tablets, a treatment for mild to moderate pain. Although the new product will be marketed as an OTC drug, it is considered a controlled substance by the SFDA. China Aoxing is one of a relatively few companies that is licensed to manufacture narcotic and controlled substance pain medication drugs in China.

The Paracetamol and Caffeine tablets will be marketed as a treatment for headache, migraine, toothache, sore throat, muscular and rheumatic pain, etc. China Aoxing said the company will launch the product in early 2009, once it receives GMP certification.

China Aoxing has two drugs on the market: Naloxone Hydrochloride injectables, a treatment for acute alcoholism and acute poisoning by opioid and non-opioid drugs, and Shuanghuangliang capsules, a TCM cough and cold remedy. In addition, the company markets a number of other TCM products, including its biggest seller, Zhongtongan.

China Aoxing is also licensed to pursue the following late stage R&D projects:

• A clinical study of Tilidine Hydrochloride tablets and capsules to treat moderate to severe pain associated with cancer and surgery, involving approximately 400 patients in several health centers in China;
• A clinical study of Codeine Phosphate Compound Medicine to treat cold and flu symptoms, involving approximately 300 patients at several health centers in China;
• A joint project with the National Institute of Drug Dependence at Beijing University to develop a sublingual Buprenorphine combo tablet to treat opioid dependence; and
• An application to the SFDA for a license to produce Pholcodine cough syrup, based on the company’s existing license to manufacture the active ingredient in Pholcodine.

Other projects for both prescription and non-prescription products are in the pre-licensing stage, according to the company.

Disclosure: none.

Comments

[huangthomas:]

It looks like China is still in the so called "polypharmacy" period, that is to mix several drugs in a single tablet or capsule. The US gave it up half century ago. To mix caffeine in the pain killer Aspirin is also a century cold practice and was abandoned at least half-a-century ago. I don't see any innovation there unless you think going back to the good old day is an "innovation". By the way acetaminophen is Tylenol, in case you don't know. There is nothing new here.

2008 Dec 15 11:37 AM