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.

This was in relation to companies' licensing agreements with Purdue. The licenses granted to Teva, Impax and Endo Pharmaceuticals preceded a decision on Jan. 7, 2008, by U. S. District Court for the Southern District of New York, in which the court ruled that Purdue Pharma hadn't 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 patents for brand illegally, but the court sided with Purdue. Purdue as a result signed an agreement with 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 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's applied to inner lining of 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 hasn't responded to non-opioid analgesics.

Medtronic is taking new approaches to delivering pain medication even a step further by stopping thought of pain altogether in brain.

Medtronic recently gained approval for RestoreULTRA, a device about the size of an ultra-slim pocket watch that's implanted under skin, usually in abdomen, and connected to spinal cord using insulated wires. The neurostimulator sends small electrical pulses to a space near spinal cord, preventing pain signals traveling through the nervous system from reaching brain. The device allows patients to tailor the electrical stimulation to pain they are experiencing using an external remote control.

Intranasal Therapeutics is conducting phase 3 trials for its drug butorphanol intranasal. The drug is indicated for management of moderate to severe pain when 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 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 potential fatal risk factors associated with improper use of 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 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 FDA. The company's appeal of a second approvable letter from Food and Drug Administration for a once-daily formulation of its pain drug Tramadol was rejected by agency.

Labopharm also is trying to introduce once-daily formulation of Tramadol, which is its lead product in various international markets, including Canada, France, Germany, Spain, Italy and the United Kingdom.

Contraception method comparison

Understanding Maxalt.

Maxalt: uses Maxalt is used to treat migraines. It helps to relieve headaches, pain and other symptoms of migraines, including sensitivity to light/sound, nausea, and vomiting. Prompt treatment allows you to get back to your normal routine and may decrease your need for other pain medications. Maxalt doesn't prevent future migraines or reduce how often you may get a headache.

Maxalt belongs to a group of drugs called triptans. It affects a certain natural chemical ( serotonin ) that constricts blood vessels in brain. It may also block other pain pathways in the brain.

Maxalt: how to use Read Patient Information Leaflet available from your pharmacist before we start using Maxalt and each time you get a refill. Ask your doctor or pharmacist if we have any questions.

Take Maxalt by mouth at first sign of a migraine, or as directed by your doctor. It may be taken with or without food, although faster relief may occur while use Maxalt when it's taken on an empty stomach. Don't take Maxalt to prevent a migraine. If there's no improvement in your symptoms, do not take any more doses of Maxalt before talking to your doctor.

If your symptoms are only partly relieved, or if your headache comes back, we may take a second dose after 2 hours or as directed by your doctor. Don't take more than 30 milligrams ( 3 doses ) in a 24-hour period. If we also take propranolol, don't take more than 15 milligrams of Maxalt in a 24-hour period. For Canadian product: according to drug manufacturer, do not exceed 20 mg in a 24 hour period.

If we have never taken Maxalt before and we have risk factors for heart disease ( see Precautions ) , you may be advised to take your first dose in your doctor's office in order to monitor for rare but serious heart problems ( e. g. , heart attack ) .

Your dosage is based on your medical condition and response to therapy. Tell your doctor if your condition does not improve or if it worsens.

Maxalt: side effects Drowsiness, dizziness, dry mouth, numbness/tingling/prickling sensations, redness ( flushing ) , tiredness/weakness may occur while use Maxalt. If these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed Maxalt because he or she has judged that benefit to you is greater than risk of side effects. Many people using Maxalt do not have serious side effects.

Chest/jaw/neck tightness can commonly occur shortly after using Maxalt. Only rarely are these signs of a serious condition. However, you mayn't be able to tell this apart from a serious reaction related to a lack of blood flow to heart, brain or other parts of body. Seek immediate medical attention if any of these unlikely but very serious ( rarely fatal ) side effects occur:

Tell your doctor immediately if any of these unlikely but serious side effects occur:

Maxalt may rarely cause a very serious condition called serotonin syndrome. The risk increases when Maxalt is taken with certain other drugs such as other " triptans " used to treat migraine headaches ( e. g. , sumatriptan, zolmitriptan ) , certain antidepressants including SSRIs ( e. g. , citalopram, fluoxetine, paroxetine ) and NSRIs ( e. g. , duloxetine, venlafaxine ) , or a certain drug to treat obesity ( sibutramine ) . Before taking Maxalt, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when we start or increase the dose of any of these medications. Seek immediate medical attention if we develop some of following symptoms:

In the unlikely event you have a serious allergic reaction to Maxalt, seek immediate medical attention. Symptoms of a serious allergic reaction include:

This isn't a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Maxalt: precautions See also How to Use section.

Before taking Maxalt, tell your doctor or pharmacist if we are allergic to it; or to other triptan migraine drugs; or if we have any other allergies.

Maxalt should not be taken if you have certain medical conditions. Before using Maxalt, consult your doctor or pharmacist if you have a history of:

Before using Maxalt, tell your doctor or pharmacist your medical history, especially of:

Tell your doctor if we have following risk factors for heart disease:

If we are at high risk for heart disease, your doctor may want to check your heart before prescribing Maxalt.

Maxalt may make we dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

Maxalt should be used only when clearly needed during pregnancy. Discuss risks and benefits with your doctor.

It's not known whether Maxalt passes into breast milk. Consult your doctor before breast-feeding.

Maxalt: interactions Your healthcare professionals ( e. g. , doctor or pharmacist ) may already be aware of any possible drug interactions and may be monitoring you for it. Don't start, stop or change dosage of any medicine before checking with them first.

Maxalt should not be taken with the following medication because very serious interactions may occur while use Maxalt:

Avoid taking MAO inhibitors ( e. g. , furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine ) for 2 weeks before, during, and after treatment with Maxalt. In some cases a serious, possibly fatal drug interaction may occur while use Maxalt.

If we are currently using any of these medications listed above, tell your doctor or pharmacist before starting Maxalt.

Before using Maxalt, tell your doctor or pharmacist of all prescription and nonprescription/herbal products we may use, especially of:

If we also take any ergotamine medication ( e. g. , dihydroergotamine or methysergide ) or any other " triptan " drugs ( e. g. , zolmitriptan, sumatriptan ) , we will need to separate your Maxalt dose from your dose of these other medications in order to lessen the chance of serious side effects. Ask your doctor how long we should wait between your doses of these drugs.

Tell your doctor or pharmacist if we also take drugs that cause drowsiness such as: certain antihistamines ( e. g. , diphenhydramine ) , anti-seizure drugs ( e. g. , carbamazepine ) , medicine for sleep or anxiety ( e. g. , alprazolam, diazepam, zolpidem ) , muscle relaxants, narcotic pain relievers ( e. g. , codeine ) , psychiatric medicines ( e. g. , chlorpromazine, amitriptyline, risperidone, trazodone ) .

Check labels on all your medicines ( e. g. , cough-and-cold products ) because they may contain drowsiness-causing ingredients. Ask your pharmacist about safe use of those products.

This document doesn't contain all possible interactions. Therefore, before using Maxalt, tell your doctor or pharmacist of all products you use. Keep a list of all your medications with you, and share list with your doctor and pharmacist.

Maxalt: overdose If overdose of Maxalt is suspected, contact your local poison control center or emergency room immediately. US residents can call US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

Maxalt: notes Take Maxalt only as needed when a migraine occurs, as directed by your doctor. Maxalt shouldn't be taken on a regular schedule. Never increase your dose of Maxalt or take it more often than prescribed by your doctor.

Certain foods/beverages or food additives ( e. g. , red wine, cheese, chocolate, monosodium glutamate ) as well as some lifestyle patterns ( e. g. , irregular eating/sleeping habits, stress ) may bring about a migraine headache. Avoiding these " triggers " may help decrease frequency of migraine headaches. Consult your doctor for more details.

Don't share Maxalt with others.

Maxalt: missed dose Not applicable.

Maxalt: storage Store Maxalt at room temperature between 59-86 degrees F ( 15-30 degrees C ) away from light and moisture. Do not store Maxalt in bathroom. Keep all medications away from children and pets.

Properly discard Maxalt when it's expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

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