China’s State FDA Approves Aoxing R & D License For Anti-Opioid Addiction Drug
by Dai Jialing
PharmAsia News
China’s State Food and Drug Administration approved a research and development license Nov. 20 for Aoxing Pharmaceutical's opioid combo tablet buprenorphine/naloxone tailored to fight the growing problem of opioid dependence in China.
Marketed under the brand name Suboxone and manufactured by Reckitt Benckiser in the U.S., buprenorphine/naloxone is the first opioid medication approved under the Drug Addiction Treatment Act of 2000 for the treatment of opioid dependence in an office-based setting,” Shao Hui, Aoxing’s senior vice president of finance, told PharmAsia News. “The primary active ingredient in Suboxone is buprenorphine and because buprenorphine is a partial opioid agonist, its opioid effects are limited compared with those produced by full opioid agonists, such as oxycodone or heroin.”
Suboxone also contains naloxone, an opioid antagonist, which discourages people from dissolving the tablet and injecting it, Shao said. It and it is placed under the tongue, as directed. Very little naloxone reaches the bloodstream, so what the patient feels are the effects of the buprenorphine,” added Shao. “However, if naloxone is injected, it can cause a person dependent on a full opioid agonist to quickly go into withdrawal.”
Headquartered in Shijiazhuang, Hubei province, Aoxing specializes in research, development, manufacturing and distribution of narcotics and pain management products. The company has two drugs – Shuanghuanglian capsules and naloxone hydrochloride injections – on the market, and it has received SFDA licenses for seven more medications including oxycodone, tilidine and pholcodine.
“The R&D license granted by SFDA is key to the narcotic drug business in China,” Shao said. “Since the raw materials themselves are highly regulated narcotic drugs, without a R&D license, the company cannot have access to starting materials for maintaining regular development work in the lab.”
“Equally important, China’s SFDA tends to issue one to three licenses for finished doses of the final product, which creates a very different, oligopoly type of competitive landscape,” added Shao.
Under the license Aoxing will cooperate with China’s National Institute of Drug Dependence (NIDD) at Beijing University to develop the new combo tablet. Aoxing has sponsored the collaboration and will manage the clinical studies next year.
"This new combo therapy is expressly designed to combine the proven effectiveness and tolerability of buprenorphine with a lower potential for misuse, underlining our commitment to this therapy area,” Shao said.
“SFDA’s approval is recognition of the trust and support that we have from them, and also speaks of our commitment to advance a new narcotic therapeutic paradigm for the Chinese market," Aoxing CEO Yue Zhenjiang said.
The formulation is the first in the Chinese market and Aoxing expects to have seven years of exclusivity in China, according to Yue.
“Even after the exclusivity period is over, due to the nature of the highly regulated narcotic drug business, we only expect no more than two licenses in total to be given out by the SFDA,” Yang Liying, Aoxing’s vice president of R&D said. “The company is planning to bring this effective medical treatment in to the Chinese market in early 2009."
By the end of 2006, there were roughly 1.2 million people addicted to opioids and registered with local health ministries in China. These registered users are potential patients for Buprenorphine/Naloxone, the company said.
“Buprenorphine is a pain-release drug as well as anti- opioid addiction drug,” Lu Lin, the director of China’s National Institute of Drug Dependence, told PharmAsia News. “Its biggest advantage against the drugs on the Chinese market is that it won’t lead to drug addiction, while other pain-release drugs do.”
There are about 10 million drug addicts in China, according to Lu.
“This combo drug is sold by other international companies in other countries, and though our company is currently focusing on the Chinese market, we may launch this product in other countries once we finish the development work in China,” said Shao.
SFDA also granted Aoxing designated manufacturer status Nov. 26, for the production of tilidine tablets and capsules, which is indicated for the relief of acute, moderate to severe, and chronic cancer-related pain. Tilidine is expected to launch in late 2008
PharmAsia News is a regular contributor to BioHealth Investor
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PharmAsia News
China’s State Food and Drug Administration approved a research and development license Nov. 20 for Aoxing Pharmaceutical's opioid combo tablet buprenorphine/naloxone tailored to fight the growing problem of opioid dependence in China.
Marketed under the brand name Suboxone and manufactured by Reckitt Benckiser in the U.S., buprenorphine/naloxone is the first opioid medication approved under the Drug Addiction Treatment Act of 2000 for the treatment of opioid dependence in an office-based setting,” Shao Hui, Aoxing’s senior vice president of finance, told PharmAsia News. “The primary active ingredient in Suboxone is buprenorphine and because buprenorphine is a partial opioid agonist, its opioid effects are limited compared with those produced by full opioid agonists, such as oxycodone or heroin.”
Suboxone also contains naloxone, an opioid antagonist, which discourages people from dissolving the tablet and injecting it, Shao said. It and it is placed under the tongue, as directed. Very little naloxone reaches the bloodstream, so what the patient feels are the effects of the buprenorphine,” added Shao. “However, if naloxone is injected, it can cause a person dependent on a full opioid agonist to quickly go into withdrawal.”
Headquartered in Shijiazhuang, Hubei province, Aoxing specializes in research, development, manufacturing and distribution of narcotics and pain management products. The company has two drugs – Shuanghuanglian capsules and naloxone hydrochloride injections – on the market, and it has received SFDA licenses for seven more medications including oxycodone, tilidine and pholcodine.
“The R&D license granted by SFDA is key to the narcotic drug business in China,” Shao said. “Since the raw materials themselves are highly regulated narcotic drugs, without a R&D license, the company cannot have access to starting materials for maintaining regular development work in the lab.”
“Equally important, China’s SFDA tends to issue one to three licenses for finished doses of the final product, which creates a very different, oligopoly type of competitive landscape,” added Shao.
Under the license Aoxing will cooperate with China’s National Institute of Drug Dependence (NIDD) at Beijing University to develop the new combo tablet. Aoxing has sponsored the collaboration and will manage the clinical studies next year.
"This new combo therapy is expressly designed to combine the proven effectiveness and tolerability of buprenorphine with a lower potential for misuse, underlining our commitment to this therapy area,” Shao said.
“SFDA’s approval is recognition of the trust and support that we have from them, and also speaks of our commitment to advance a new narcotic therapeutic paradigm for the Chinese market," Aoxing CEO Yue Zhenjiang said.
The formulation is the first in the Chinese market and Aoxing expects to have seven years of exclusivity in China, according to Yue.
“Even after the exclusivity period is over, due to the nature of the highly regulated narcotic drug business, we only expect no more than two licenses in total to be given out by the SFDA,” Yang Liying, Aoxing’s vice president of R&D said. “The company is planning to bring this effective medical treatment in to the Chinese market in early 2009."
By the end of 2006, there were roughly 1.2 million people addicted to opioids and registered with local health ministries in China. These registered users are potential patients for Buprenorphine/Naloxone, the company said.
“Buprenorphine is a pain-release drug as well as anti- opioid addiction drug,” Lu Lin, the director of China’s National Institute of Drug Dependence, told PharmAsia News. “Its biggest advantage against the drugs on the Chinese market is that it won’t lead to drug addiction, while other pain-release drugs do.”
There are about 10 million drug addicts in China, according to Lu.
“This combo drug is sold by other international companies in other countries, and though our company is currently focusing on the Chinese market, we may launch this product in other countries once we finish the development work in China,” said Shao.
SFDA also granted Aoxing designated manufacturer status Nov. 26, for the production of tilidine tablets and capsules, which is indicated for the relief of acute, moderate to severe, and chronic cancer-related pain. Tilidine is expected to launch in late 2008
PharmAsia News is a regular contributor to BioHealth Investor
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