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Pharmaceuticals from Marijuana
Pages 133-155

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From page 133...
... regulates marijuana and how marijuana's status as a controlled substance represents a potential barrier to developing cannabinoid medications. Despite rather daunting odds, one cannabinoid product has been on the market for more than a decade: dronabinol, or synthetic THC.
From page 134...
... The IND submission contains a plan for human clinical trials and documents the results of preclinical testing. If the FDA cloes not contest the IND within 30 clays, the manufacturer may proceed to concluct clinical tests of the new drug in humans.
From page 135...
... But even a relatively straightforward passage through clinical testing consumes most of the $200 million to $600 million spent to develop the average drug.* And since only about one in five drugs that begin Phase I eventually secures FDA approval, clinical trials represent a significant financial risk.
From page 136...
... The process begins with the discovery of a biologically active drug and ends with the granting of approval for its sale by the Food and Drug Administration. Approximately one in five drugs that begin Phase I trials secure FDA approval.
From page 137...
... This is usually a far simpler and less expensive process than the initial NDA, since the drug in question has already been proven safe and its side effects have been well characterized. Generally, the pharmaceutical company must conduct one or two new Phase III clinical studies to demonstrate an approved drug's efficacy in treating an additional indication, a process estimated to cost $10 million to $40 million.
From page 138...
... It allows patients with life-threatening diseases, such as AIDS or cancer, access to experimental medications before they have received approval for marketing. Once a drug enters Phase III clinical trials, treatment INDs may be issued to allow patients who are not part of the trials to use the drug as long as no comparable approved medication exists.
From page 139...
... The possibility that a drug might be scheduled under the Controlled Substances Act represents a major deterrent to its development by a pharmaceutical company because scheduling can limit its profits in two main ways. First, the company must document the drug's abuse potential, which adds to research costs as well as the time it takes to bring the drug to market.
From page 140...
... Both the FDA and the DEA tightly regulate research on Schedule I substances, even when it does not involve human trials. For example, scientists studying cannabinoids found in marijuana plants must first receive DEA approval of both their experimental plans and their research facilities (see Chapter 11~.
From page 141...
... These compounds therefore represent more attractive candidates for drug development than their marijuana-derived counterparts. Nevertheless, since a cannabinoid from a source other than marijuana has yet to be tested in clinical trials in the United States, it remains to be seen whether such compounds will continue to remain unscheduled.
From page 142...
... To market such a cannabinoid as a medicine, the manufacturer would first have to petition the DEA to have it rescheduled a strong disincentive to developing such drugs. Of course, the rescheduling of marijuana to a less restrictive category would drastically change the outlook for cannabinoid drug development.
From page 143...
... These include anxiety, confusion, dizziness, mood changes, sleepiness, and thinking abnormalities. In two recent clinical trials about onethird of patients who received dronabino]
From page 144...
... This gain was especially welcome, since profits from medication for chemotherapy-induced nausea were beginning to decline as a result of the introduction of more effective antinausea drugs, such as ondansetron, that are also unscheduled. Since its commercial introduction in 1985, Marinol had been listed in the most restrictive schedule for medically useful controlled substances along with morphine, cocaine, and other prescription medications with a "high potential for abuse." While such a distinction clearly limited Marinol's availability, it did not delay the drug's initial entry into the market because the scheduling decision was made by the DEA prior to FDA approval; nor did any delays occur as a result of state scheduling laws.
From page 145...
... Currently, 80 percent of the patients using Marinol take it to relieve AIDS wasting, 10 percent to relieve chemotherapy-induced nausea, and the remaining population for off-label conditions. The latter group is thought to consist mainly of Alzheimer's patients; in a recent study the drug showed promise in treating appetite loss and behavioral disturbances associated with that disease.
From page 146...
... The company is also exploring oral formulations that would allow dronabinol to be absorbed directly into the blood vessels that lie beneath the tongue, rather than swallowed as a pill. Other researchers are exploring the use of rectal suppositories to deliver THC or dronabinol, but this method is considerably slower than the previous four; it is also likely to be acceptable to fewer patients.
From page 147...
... currently costs about $200 per month for its most common use to combat AIDS wasting; the cost of treating chemotherapy-induced nausea is lower, since it is not a chronic condition. Several patients who spoke at the IOM's public workshops found Marinol's price to be prohibitive and said that one of the advantages of using marijuana for medical purposes was its relatively low cost.
From page 148...
... Turning from this specific case, we now examine the factors that are likely to determine whether new medicines will continue to be developed from marijuana, the outlook for drugs based on individual cannabinoid compounds, and the prospects for developing medicines from the entire marijuana plant. PROSPECTS FOR NOVEL CANNABINOID MEDICATIONS The potential therapeutic value of cannabinoids extends far beyond remedies for nausea and weight loss.
From page 149...
... Other types of market protections, such as orphan drug status, confer similar advantages. As discussed earlier, scheduling under the Controlled Substances Act tends to decrease the market for a drug, as do adverse side effects and interactions with other medications.
From page 150...
... First, nearly all of the investigators listed are either small companies or individuals, who are generally willing to assume greater commercial risk than a large pharmaceutical company. Because such small enterprises typically obtain funding from venture capital, stock offerings, or collaborations with larger companies rather than from sales, they can pursue riskier goals.
From page 151...
... First, under the Controlled Substances Act, such compounds would initially be placed in Schedule I; even if the necessary rescheduling proceeded smoothly, controlled substances carry a stigma that limits their sales potential. An additional deterrent to developing cannabinoids from the marijuana plant is the fact that such natural products are ineligible for product patents.
From page 152...
... Another group of potentially lucrative compounds act by binding cannabinoid receptors without activating them, thereby producing the opposite effect of molecules that activate the receptor. Similar effects also could be achieved with compounds that interfere with receptor binding by natural cannabinoids.
From page 153...
... Along with many of the downside risks associated with the approval and scheduling of cannabinoid drugs, medicinal marijuana faces several additional barriers to development. Thus, it is not surprising that FDA approval has never been sought for the medical use of mari~uana.
From page 154...
... Moreover, marijuana could only be brought to market if it were rescheduled to acknowledge its "accepted medical use," according to DEA standards. To meet that requirement, a compound must have a known and reproducible chemical structure; its safety and efficacy must be proven; its use must be approved by qualified experts; and scientific evidence for its medical use must be widely accepted.
From page 155...
... 1996. "Endogenous and synthetic cannabinoids: Recent advances." CNS Drug Reviews 2:429451; Striem S


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