New delivery systems advance pain management medications
Advances in the pharmaceutical industry regarding pain management have made life easier for people living with chronic pain and have provided relief for consumers suffering from simple aches to severe pain.
One of the more recent developments in pain management was the decision by Teva, Impax Laboratories and Dava Pharmaceuticals to discontinue distribution and sales of generic versions of Purdue Pharma’s narcotic pain medication OxyContin, called oxycodone hydrochloride controlled-release.
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This was in relation to the companies’ licensing agreements with Purdue. The licenses granted to Teva, Impax and Endo Pharmaceuticals preceded a decision on Jan. 7, 2008, by the U.S. District Court for the Southern District of New York, in which the court ruled that Purdue Pharma had not committed unfair conduct in obtaining its OxyContin patents and that its patents are enforceable, thus blocking a generic from being on the market. The generics companies had originally argued that Purdue received the patents for the brand illegally, but the court sided with Purdue. Purdue as a result signed an agreement with the generics companies allowing them to keep their generic versions on the market for a specific period of time, which ended recently.
Oxycodone hydrochloride controlled-release and OxyContin dominated the codeine market in sales in 2007. The drugs had combined sales of more than $2.2 billion, which represented more than 60 percent of the codeine market, according to IMS Health. Purdue will continue to sell and distribute OxyContin tablets.
Finding new methods of treating breakthrough cancer pain, BioDelivery Sciences International has submitted an application with the Food and Drug Administration for the drug BEMA Fentanyl.
BEMA Fentanyl is a small, dissolvable, polymer disc that is applied to the inner lining of the cheek.
The application was submitted in October 2007, and a final decision is expected by the FDA in August. The Fentanyl market in 2007 exceeded $1.5 billion in sales, according to IMS Health.
Mandipharma is in phase 3 clinical trials for its transdermal patch buprenorphine in 5 mg, 10 mg and 20 mg. strengths. It will be marketed under the brand name Norspan. The drug is indicated to treat chronic severe pain that has not responded to non-opioid analgesics.
Medtronic is taking new approaches to delivering pain medication even a step further by stopping the thought of pain altogether in the brain.
Medtronic recently gained approval for RestoreULTRA, a device about the size of an ultra-slim pocket watch that is implanted under the skin, usually in the abdomen, and connected to the spinal cord using insulated wires. The neurostimulator sends small electrical pulses to a space near the spinal cord, preventing pain signals traveling through the nervous system from reaching the brain. The device allows patients to tailor the electrical stimulation to the pain they’re experiencing using an external remote control.
Intranasal Therapeutics is conducting phase 3 trials for its drug butorphanol intranasal. The drug is indicated for the management of moderate to severe pain when the use of an opioid analgesic is appropriate. Intranasal Therapeutics is marketing the drug for treatment of migraine headaches. The company is looking to grab a piece of the near $1 billion migraine-treatment market now that Imitrex has just lost its patent and faces generic competition by such companies as Ranbaxy and Aurobindo.
The FDA and Cephalon in September issued warnings to patients and doctors about the potential fatal risk factors associated with improper use of the cancer pain management drug Fentora by patients using it to treat migraines or other types of short-term pain.
While working on the warnings, Cephalon submitted a supplemental application to the agency to market Fentora as a "breakthrough pain" drug that would treat chronic pain conditions that could include lower back and neuropathic pain.
Like Cephalon, Labopharm has been working on getting an approval from the FDA. The company’s appeal of a second approvable letter from the FDA for a once-daily formulation of its pain drug Tramadol was rejected by the agency.
Labopharm also is trying to introduce the once-daily formulation of Tramadol, which is its lead product in various international markets, including Canada, France, Germany, Spain, Italy and the United Kingdom.
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