FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain

The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.

This is the only FDA approved morphine sulfate oral solution available at this concentration. Although the use of this medicine to manage pain has been common practice for many years, this form and concentration of morphine was not FDA approved until now.

Today’s action is part of the FDA’s unapproved drugs initiative. As part of this program, the FDA has worked with the manufacturer of the now-approved product, Roxane Laboratories, to ensure that there is enough drug available for patients. The FDA will also be working with patient organizations and prescribers so that they are aware that an approved product is available, and can notify the FDA if there are any problems with availability.

“An important goal of the unapproved drugs initiative is to make sure that marketed drugs meet current FDA standards,” said Douglas Throckmorton, M.D., deputy director for the FDA’s Center for Drug Evaluation and Research. “Our action today reflects a careful balance between ensuring patient access to necessary medicines, while making sure companies comply with the law.”

One benefit of the FDA approval process is a requirement for manufacturers to provide sufficient information on how to safely prescribe and use a drug. Manufacturers may also have to establish additional safety measures to manage unique risks of a medicine. For this formulation of morphine, the manufacturer had to develop a safety program prior to approval to address the known risks of morphine misuse, abuse and overdose.

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ETHEX Corporation Issues Voluntary Nationwide Recall

ETHEX Corporation, a subsidiary of KV Pharmaceutical Company (NYSE: KVa/KVb), is issuing a voluntary expansion to the retail level of a previously announced recall on certain products. The recall on the products listed below had previously been issued to the wholesale level, but is now being expanded to the retail level. The Company is taking this action as a precautionary measure, because the products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice (cGMP). This additional level of recall is to further remove recalled products from the marketplace.

Patients who may have these products in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medications may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.

Expanded Recall to Retail Level Includes the Following Products:

* Morphine Sulfate Extended-Release Tablets 15mg, 30mg & 60mg (All Strengths)
* Morphine Sulfate Immediate-Release Tablets 15mg & 30 mg (All Strengths)
* Dextroamphetamine Sulfate Tablets 5mg & 10mg (All Strengths)
* Isosorbide Mononitrate Extended-Release Tablets 30mg, 60mg & 120mg (All Strengths)
* Propafenone HCl Tablets 150mg, 225mg & 300 mg (All Strengths)

Any retail customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the Company is unable to determine when distribution of these products will resume.

Patients with questions about the recall should call the telephone number above, or contact their healthcare providers. Any adverse reactions experienced with the use of these products should also be reported to FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch .

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Georgia State Study First to Pinpoint Why Analgesic Drugs May be Less Potent in Females than in Males

Investigators at Georgia State University’s Neuroscience Institute and Center for Behavioral Neuroscience are the first to identify the most likely reason analgesic drug treatment is usually less potent in females than males. This discovery is a major step toward finding more effective treatments for females suffering from persistent pain.

“Opioid-based narcotics (such as morphine) are the most widely prescribed therapeutic agents for the alleviation of persistent pain; however, it is becoming increasingly clear that morphine is significantly less potent in women compared with men. Until now, the mechanism driving the phenomenon was unknown,” said Anne Murphy, a Georgia State Professor of Neuroscience and member of the Center for Behavioral Neuroscience, who conducted the research with Dayna Loyd.

Murphy recently solved the mystery with findings printed in the December issue of The Journal of Neuroscience that show that previously reported differences in morphine’s ability to block pain in male versus female rats are most likely due to sex differences in mu-opioid receptor expression in a region of the brain called the periaqueductal gray area (PAG).

Located in the midbrain area, the PAG plays a major role in the modulation of pain by housing a large population of mu-opioid receptor expressing neurons. Morphine and similar drugs bind to these mu-opioid receptors analogous to a ‘lock and key’ and, ultimately, tell the brain to stop responding to pain signals to the nerve cells resulting in the reduced sensation of pain.

Using a series of anatomical and behavioral tests, Murphy and Loyd were able to determine that male rats have a significantly higher level of mu-opioid receptors in the PAG region of the brain compared with females. This higher level of receptors is what makes morphine more potent in males because less drug is required to activate enough receptors to reduce the experience of pain. Interestingly, when they used a plant-derived toxin to remove the mu-opioid receptor from the PAG, morphine no longer worked, suggesting that this brain region is required for opiate-mediated pain relief.

Additional tests also found females reacted differently to morphine depending on the stage of their estrous cycle. These findings indicate that steroid hormones may affect mu-opioid receptor levels in the region of the PAG that are essential for analgesia and also suggest that the actions of morphine are estrous stage-dependent.

“Interestingly, sex is not the only factor that has been shown to affect the potency of various pharmacological agents. Recent studies have reported an influence of age and ethnicity, and further argue for the inclusion of a wide range of study subjects in pain management research,” Murphy said. “In addition, despite the rapidly mounting evidence regarding the limitations of opiates in treating persistent pain, opioid-based drugs remain the primary pharmacological tool for pain management. Clearly additional research with the inclusion of female subjects needs to be devoted to determining a more potent treatment for persistent pain in women.”

Murphy’s work was supported by grants from the National Institutes of Health.

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