Last week Lupin Pharmaceuticals, Inc. issued a press release announcing that it has received final FDA approval to market pregabalin, the generic version of Lyrica ® in the U.S.
Lyrica (pregabalin) was the first drug ever to be approved for the treatment of fibromyalgia . In addition to fibromyalgia, it has also been approved by the FDA for:
Treatment of neuropathic pain associated with diabetic peripheral neuropathy.
Treatment of post herpetic neuralgia.
Use an adjunctive therapy for adult patients with partial onset seizures.
Lupin's pregabalin capsules, to be available in 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg doses, are the AB-rated generic equivalent of Lyrica. An AB rating means that the generic drug has been studied and has demonstrated that it is bioequivalent to the original drug.
According to the FDA, "Bioequivalence of different formulations of the same drug substance involves equivalence with respect to the rate and ...
It has been about ten years since the United States Drug Enforcement Administration (DEA) launched what some feel is a targeted war on drugs, the battleground being your Doctor's office. The DEA feels there has continued to be a diversion of prescription narcotics for use on "the street." I am not sure this is what they had in mind for Main Street.
The focus on physicians is perhaps the least resistant path to the easier drug bust; after all, physicians are supposed to maintain records of prescriptions written, and document the reasoning behind and the plans for the continued use of a prescription drug. That drug dealer out on the street is a tougher collar.
Physicians have been put through the wringer of the American judicial system, on charges ranging from drug dealing to murder, charges rooted in the over-prescribing of narcotic medications. There is a certain irony here, as such woes have befallen physicians in parallel with the development of drugs that have all...
So, what is a doctor to do about the abuse of pain-killers? If doctors begin to act like police officers, then the doctor-patient relationship suffers. But doctors can keep an eye out for certain risk factors which may indicate a current or future problem with narcotics in a given patient. A recent article in the "Annals of Internal Medicine" discusses such risk factors, which include mood disorders, other addictions, younger age, and male sex. Unfortunately, there are few novel treatments for pain, and therefore doctor and patient are often left only with narcotics, which have been around for a long, long time. It would be helpful to have other weapons in the fight against chronic or recurrent pain, weapons which are less addictive. In the meantime, industry and the medical profession are looking at ways to combat abuse of prescription pain-killers. For example, Oxycodone will soon be available embedded in a viscous gel. In this form, the pill cann...
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