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Marinol

Marinol, a registered trademark of Unimed Pharmaceuticals, Inc. is the commercial name for a product containing dronabinol, which is synthetic Δ9-tetrahydrocannabinol. more...

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Δ9-THC is a naturally occurring component of marijuana.

Marinol is the only FDA-approved cannabinoid and is prescribed as an appetite stimulant, primarily for AIDS and chemotherapy patients. Compare Sativex, a mouth spray for neuropathic pain of multiple sclerosis sufferers approved for use in Canada.

Many users complain that not only is the cost of Marinol greater than the cost of the amount of marijuana needed to produce the same effect, but it is also lacking in many of the properties of the whole plant, which contains hundreds of different cannabinoids. However, Marinol is available for free to those who can demonstrate their financial need to Roxane and Unimed Pharmaceuticals. In addition, it takes over an hour for Marinol to reach full effect, but its duration is longer and it is available in controlled dosages, avoiding the uncontrolled strengths that occur when smoking marijuana. It is difficult to maintain an exact level of effect (which is important to most medical users), as well as making its use difficult for people suffering from nausea and vomiting, since they often expel the medication before it takes effect.

Regulatory history

Since at least 1986, the trend has been for THC in general, and especially the Marinol preparation, to be downgraded to less and less stringently-controlled Schedules of controlled substances, in the U.S. and internationally.

On July 13, 1986, the Drug Enforcement Administration issued a Final Rule and Statement of Policy authorizing the "Rescheduling of Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules From Schedule I to Schedule II"(DEA 51 FR 17476-78). This permitted medical use of Marinol, albeit with the severe restrictions associated with Schedule II status. For instance, refills of Marinol prescriptions were not permitted. At its 1045th meeting, on April 29, 1991, the Commission on Narcotic Drugs, in accordance with article 2, paragraphs 5 and 6, of the Convention on Psychotropic Substances, decided that delta-9-tetrahydrocannabinol (also referred to as delta-9-THC) and its stereochemical variants should be transferred from Schedule I to Schedule II of that Convention. This released Marinol from the restrictions imposed by Article 7 of the Convention.

An abstract published in the April-June 1998 issue of the Journal of Psychoactive Drugs found that "Healthcare professionals have detected no indication of scrip-chasing or doctor-shopping among the patients for whom they have prescribed dronabinol". The authors suggested that Marinol had a low potential for abuse.

In 1999, Marinol was rescheduled from Schedule II to III of the Controlled Substances Act, reflecting a finding that THC had a potential for abuse less than that of LSD, cocaine, and heroin. This rescheduling comprised part of the argument for a 2002 petition for cannabis rescheduling in the United States, in which petitioner Jon Gettman noted, "Cannabis is a natural source of dronabinol (THC), the ingredient of Marinol™, a Schedule III drug. There are no grounds to schedule cannabis in a more restrictive schedule than Marinol™".

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Involuntary weight loss: interview with Lisa Capaldini, M.D
From AIDS Treatment News, 3/25/05 by John S. James

On April 19, 2005 we spoke to Lisa Capaldini, M.D., an HIV specialist in San Francisco who alerted us to metabolic complications of HIV and antiretroviral treatment in 1997 (see AIDS Treatmenl News #277). We asked Dr. Capaldini for a brief overview of treating involuntary weight loss today.

Dr. Capaldini explained that a small but important group of patients is still wasting, although their HIV viral load is controlled. And a larger group has difficulty maintaining weight, due to queasiness, nausea, and anorexia (loss of appetite) with antiretroviral treatment. An additional problem is that if patients cannot eat, they' cannot take some of their medications with food as required. So involuntary weight loss can be a problem both for those with active wasting, and those who need help with antiretroviral side effects in order to be able to eat properly.

We noted a recent report on a new formulation of Megace (megestrol acetate), an appetite stimulant, to improve its absorption [1]--and asked about the reputation of megace for putting on weight by increasing fat and water--not helpful when the problem is muscle wasting. Dr. Capaldini agreed that this is a relevant concern. But as she explains to her patients, there are two issues: the body must get enough calories, and then must use them properly.

She noted that some doctors make the mistake of just giving Oxandrin (oxandrolone, an anabolic steroid, which helps build muscle mass), when the real problem is that the patient will not eat. Instead, these patients need an appetite stimulant, such as Megace, or Marinol--and then a separate assessment of whether there is a lack of lean body mass. One cannot reliably tell just by looking whether someone has too little lean body mass. Dr. Capaldini uses BIA (bioelectric impedance) to help determine whether this is the case.

We asked about the common belief that men using megace may need treatment with testosterone as well. Dr. Capaldini explained that there are two situations where this is true. Rarely, megace may cause adrenal dysfunction. And much more commonly, many patients who are being treated for weight loss have low testosterone already, and need treatment for it.

Dr. Capaldini noted that oxandrolone (used for treating muscle wasting) is a pure anabolic--it helps increase muscle mass, but does not have any androgenic (masculinizing) effect at all (this is why women can take the frill dose). In fact, oxandrolone can cause lower levels of testosterone. Therefore many studies of oxandrolone now give testosterone to help get everybody to a certain baseline level. Dr. Capaldini believes that all patients with HIV-associated weight loss should be screened for low testosterone (hypogonadism) and for depression.

Dr. Capaldini noted that just as there is no right antiretroviral for everyone, nutritional problems also can be multifactorial. Different patients may need very different approaches.

She also noted that for many people with HIV, HAART treatment (and medications to treat HAART side effects) will be lifelong; therefore it is important that these treatments be flexible and easy to use. This is why the new version of Megace is now being tested. [1] The current formulation can be a problem, because it is an appetite stimulant, yet must be taken with food in order to be absorbed well by the body. The new formulation (still experimental; it could be available as early as mid summer 2005) has a much smaller particle size so that it can dissolve better, even when the patient has not been able to eat.

References

[1.] RA Femia. Megestrol acetate nanocrystal oral suspension: results of dose-escalating studies under fed and tasting conditions. AmfAR National HIV/AIDS Update Conference, April 10-April 13, 2005 in Oakland, California, http://www.am far.org/nauc.

COPYRIGHT 2005 John S. James
COPYRIGHT 2005 Gale Group

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