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Metaxalone, a New Skeletal Muscle Relaxant

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Metaxalone, a New Skeletal Muscle Relaxant Metaxalone, a new skeletal muscle relaxant LLOYD W. MOREY, A.S., B.S., D.O.,* Milwaukee, identification of the poisoned arrows in the Orinoco Wisconsin, and ALLAN R. CROSBY, B.A., D.O., River basin and the work of Claude Bernard in Wauwatosa, Wisconsin 1857. 1 Those curarelike substances acted by pre- venting muscle motor end-plate depolarization from acetylcholine. In 1935, King isolated the alkaloid d-tubocurarine from curare. It was not until 1942 The compound 5- ( 3,5-dimethylphenoxy-methyl ) 2 that it was first used for general anesthesia by oxazolidinone ( AHR-438, metaxalone, or Skelaxin ) Griffith and Johnson. These curariform compounds is a new skeletal muscle relaxant of central action. are characterized as being quaternary ammonium There are many compounds in this field. They are compounds and by their peripheral action. They related to, or are derivatives of, curare, curarelike are: chondodendron tomentosum (Intocostrin ), tu- substances, or tranquilizers. None of the previous bocurarine chloride, dimenthyl tubocurarine iodide substances used by us have seemed very successful ( Metubine), succinylcholine chloride ( Anectine in achieving symptomatic relief from the pain and and others ), and gallamine triethiodide (Flaxedil). tension of muscular spasm. Of course each physician Beckman considers these drugs as potentially has his own "favorite," but no single compound very dangerous. They have to be given by intra- seems to be outstandingly effective for everyday venous drip under constant expert supervision. He clinical use. cites a study of almost 600,000 surgical anesthestic Before the introduction of the skeletal muscle cases by Beecher and Todd in 1954, in which it relaxants, the allopathic physician could offer his was found that death associated with the use of patient nothing more than addicting analgesics, striated muscle relaxants was six times as high as mud plasters, and prolonged bed rest. The adjunc- without them! These agents will antagonize hypo- tive use of skeletal muscle relaxants with osteo- calcemia and hypokalemia, the effect of a fever pathic manipulation should enhance the patients blocking the myoneural conduction, and reduced chances of responding more quickly to treatment for blood flow to respiratory muscles. They are metabo- skeletal muscular problems. lized in muscles, liver, and kidneys. Ether has a curarelike action. General considerations Another group of muscular relaxants are related to cinchona derivative, quinine. Quinine has been Historical notes • The class of drugs known as most useful to prevent leg cramping, and in myo- muscular relaxants has come a long way since tonia congenita. Its antimalarial activity has been °Address, 7729 W. Burleigh St. well documented. JOURNAL A.O.A., VOL. 62, FEB. 1963 517/61 The third group of muscle-relaxing agents consists of tremors or small muscle spasm. It fails to alter of those having a central action. They are usually blood pressure, heart rate, temperature, the electro- taken by the oral route. These compounds appear cardiogram, or electromyographic studies. It does to be less toxic in general, and they may be given not alter gait, posture, or alertness. orally and without such close supervision. However, a great variety of side effects are noted. Renal and Previous clinical studies • A previous report on hepatic function may be impaired. the clinical use of metaxalone in 952 patients re- Included in this group are: mephenesin (Tolserol lated that there were some side effects in 82 (8.5 and others ), carisoprodol ( Soma, Rela), zoxazola- per cent) . However, it must be remembered that mine ( Flexin), methocarbamol (Robaxin), styra- when patients know they are taking a new drug, mate ( Sinaxar), and various tranquilizers. they become overly concerned about their bodily functions and feelings. This is easily demonstrated Ideal characteristics of a muscle relaxant • The by noting that of those patients in the study who selection of a medication to use with an acute or were receiving up to 2,000 mg. per day, 11 per cent chronic muscular spasm should meet the following noted side effects. Among those patients taking basic requirements: 2,400 to 9,200 mg. per day, only 7 per cent reported 1. Safety. There must be no interference with any side effects. In this instance the number of side vital process. Addiction potential should be absent. effects were inversely proportional to an increase Patient mismanagement should not result in severe in dosage. morbidity. The side effects noted during a treatment period 2. Side effects. These should be minimal or ab- of from 1 to 345 days were: nausea, 23 cases; sent. Those that occur should not be embarrassing drowsiness, 10 cases; gastrointestinal upset, 8 cases; to the patient or interrupt any activity which he vertigo, 6 cases; elevated blood urea nitrogen, 6 was able to do previously. cases; and headache, 6 cases. Also reported were 3. Action. It should be immediate but not neces- diarrhea, nervousness, rash, vomiting, pruritus, ede- sarily prolonged over 12 hours. ma, blood pressure elevation, constipation, border- 4. Dosage. Availability for use by oral, rectal, line leukopenia, anorexia, excessive perspiration, intramuscular, and intravenous routes is desirable. and insomnia. Probably of significance (2 per cent 5. Performance. An ideal muscle relaxant would of all patients) was the increased frequency of relieve muscular spasm promptly, allowing a mini- drowsiness, headache, and elevated blood urea ni- mal loss of time from work, without incurring side trogen in the higher dosage range (over 2,400 mg. effects or a high financial burden. per day). Background information on metaxalone Present clinical study Methods and materials • The purpose of this Pharmacology • Metaxalone is a bitter, ordorless, clinical study was to compare metaxalonet with a white crystalline powder which melts at about 122° placebo in a double-blind study. Neither patient C.3 It is practically insoluble in water. nor physician knew which patient was receiving This medication acts as an interneuronal depres- the medication and which the placebo. The cap- sant. The oral LD-50 in rats is one half that of sules used were identical in size, color, and weight. mephenesin. Acute toxicity results in sedation pro- A total of 61 patients participated in this study, gressing through hypnosis and then death from all of whom had a diagnosis involving striated mus- respiratory failure. Prolonged dosage at eight times cular spasm. They were all considered "tough" cases the maximum recommended dose in animals re- —those not expected to improve rapidly. All were sults in a moderate reduction in hemoglobin and given two tablets four times daily, after meals and packed-cell volume. This compound is unique at bedtime; the amount of the metaxalone per cap- among muscle relaxants in that it markedly pro- tects experimental animals against convulsive sei- sule was 400 mg., for those who received it. zures from strychnine, probably by acting on the For all patients, the following tests were per- caudal reticular formation. In contradistinction, formed before the medication was begun: complete carisoprodol results in electroencephalographic hy- blood count, urinalysis, blood urea nitrogen, and persynchronous spiking. serum glutamic oxalopyruvic transaminase. These same tests were checked 3 or more weeks later to Metaxalone appears to have very little tranquiliz- see if there had been any changes. A sufficient ing effect, anti-inflammatory activity, or analgesic property. It does not alter the sciatic inhibition of number of laboratory tests to allow evaluation were the patellar reflex. It will completely block the performed on 51 of the 61 patients. crossed extension reflex, whereas phenyramidol Forty-nine of the 61 patients displaying one (Analexin) will only partially block this reflex. It form of muscular spasm or another also received does not appear to have any value in the treatment t Supplied for this study as Skelaxin, by the A. H. Robins Company, Inc., who also furnished the placebo. 518/62 osteopathic manipulative therapy where indicated. tionalized. Another patient complained of nausea; this patient is considered to have a moderate anxi- Results • Of the 61 patients, 36 were considered ety neurosis. Another patient complained of vertigo, to have good to excellent results. Twenty-five had and there was a question as to whether or not he fair to poor results. Of the 36 who had good to had had a concomitant episode of influenza. excellent results, 19 were on the placebo and 17 Of the 5 patients on the placebo, one complained were on metaxalone. of swelling in the anterior cervicoclavicular area, Of the 49 patients who also received osteopathic another of syncope, one of diarrhea, another of manipulative therapy, 24 were on metaxalone and pruritus and "burning" of the eyes, and the fifth 25 on the placebo. Thirteen of those on metaxalone of malaise. did well, and 17 of those on the placebo did well, with the adjunctive use of osteopathic manipula- Laboratory studies • Table I shows the laboratory tion. Of the 12 patients who did not receive osteo- results on the 51 patients on whom adequate pathic manipulative therapy, 4 of the 6 who were studies were done. Laboratory analyses of the al- on metaxalone had good to excellent results, where- bumin and sugar content of the urine, as well as as only 1 of the 6 patients on the placebo did well. microscopic examination, were carried out, but the All patients were given a questionnaire to fill out results showed so little variation as to be totally 1 week after they had started the medication. This insignificant. consisted of four main questions : (1) Has this drug In the 16 males on metaxalone, a small average helped you? (2) When did you first notice improve- increase was noted in hemoglobin fraction, lympho- ment? (3) In what ways did this drug help you? cyte count, and urinary specific gravity, while small (4) Was this drug of more help than others? average decreases were found in the segmented In evaluating the first question, it was found that neutrophil count, serum glutamic oxalopyruvic 17 of the 30 patients who were on metaxalone stated transaminase, and blood urea nitrogen.
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