Safety Evaluation of Penfluridol, a New Long-Acting Oral Antipsychotic Agent

¹ Spring Grove State Hospital, Baltimore, Md., the Maryland Psychiatric Research Center, Baltimore, Md., and McNeil Laboratories, Inc., Fort Washington, Penn.

In a 17-week dose range study, penfluridol was safe and effective in controlling the psychiatric symptomatology of 12 chronic psychotic patients. Administered orally once a week at starting doses of 5 or 10 mg and final (maximum) doses of 160 or 200 mg, penfluridol had no clinically significant effect on vital signs or laboratory test results. Adverse reactions among patients receiving penfluridol were no more frequent than among control patients receiving commonly used neuroleptic medications. Extrapyramidal reactions with penfluridol occurred only rarely and then usually only at doses of 100 mg or more, considerably above the therapeutically effective dosage range of 60 to 80 mg. Eight of the 12 patients on penfluridol received doses of 160 mg or higher, without any extrapyramidal symptoms. Sedation, common among the control patients on various phenothiazines, was virtually absent among patients on penfluridol.

On the Brief Psychiatric Rating Scale (BPRS), the Nurses' Observation Scale for Inpatient Evaluation (NOSIE), and a Clinical Global Impression scale (CGI), penfluridol was at least as effective as the conventional phenothiazines received by the control group. This was despite the fact that the doses of penfluridol were adjusted upward by protocol, regardless of the therapeutic response, and that the doses of the phenothiazines had previously been established as optimal.

The primary objective of this study was to examine carefully the safety of this new long-acting oral compound. The results demonstrated its safety and probable therapeutic effects. In light of the advantages of an oral drug effective for one week following a single dose, further clinical study of penfluridol is definitely warranted.

Note:

This study was supported by McNeil Laboratories, Inc., Fort Washington, Penn., and administered by Friends Medical Science Research Center, Inc. The authors express their appreciation for the encouragement and cooperation of the former Spring Grove State Hospital superintendent, Dr. Bruno Radauskas, the former clinical director, Dr. D. Jolbitado, and the hospital clinical staff. Special appreciation is expressed to Dr. George E. Crane for his assistance as consultant in examining patients for side effects, Mrs. Cecilia Coughlin and her staff for nursing care, and Miss Carolyn Sitkowski for data processing and analyses.

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