Monday, March 30, 2009

Patent application for stuttering medication

A reader dug out this patent application for a stuttering medication: (I couldn't get the line breaks working...)

Treatment of stuttering and other communication disorders with norepinephrine re-uptake inhibitors

USPTO Application #: 20070032554
Title: Treatment of stuttering and other communication disorders with norepinephrine reuptake inhibitors
Abstract: Provided are methods and medicaments for treating stuttering or another communication disorder, comprising administering to a patient in need of such treatment an effective amount of a selective norepinephrine reuptake inhibitor. (end of abstract)

Agent: Eli Lilly & Company - Indianapolis, IN, US
Inventor: Douglas Kenneth Kelsey
USPTO Applicaton #: 20070032554 - Class: 514651000 (USPTO)

Treatment of stuttering and other communication disorders with norepinephrine reuptake inhibitors description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20070032554, Treatment of stuttering and other communication disorders with norepinephrine reuptake inhibitors.

Brief Patent Description - Full Patent Description - Patent Application Claims


BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates to the fields of pharmaceutical chemistry and central nervous system medicine. More specifically, the present invention relates to methods of treating communication disorders, such as stuttering, in children, adolescents, and adults by administering selective norepinephrine reuptake inhibitors to patients in need of such treatment.

[0003] 2. Description of Related Art

[0004] The Diagnostic and Statistical Manual ofMental Disorders, Fourth Edition (DSM-IV) (1994), American Psychiatric Association, Washington, D.C., pp. 55-65, describes a number of communication disorders usually first diagnosed in infancy, childhood, or adolescence. These include stuttering, expressive language disorder, mixed receptive-expressive language disorder, phonological disorder, and communication disorder not otherwise specified. Stuttering is perhaps the most well known of these disorders.

[0005] Stuttering is a speech disorder in which the normal flow of speech is disrupted by frequent repetitions or prolongations of speech sounds, syllables, or words, or by an individual's inability to start a word. The speech disruptions may be accompanied by rapid eye blinks, tremors of the lips and/or jaw, or other struggle behaviors of the face or upper body that a person who stutters may use in an attempt to speak. Certain situations, such as speaking before a group of people or talking on the telephone, tend to make stuttering more severe, whereas other situations, such as singing or speaking alone, often improve fluency. Stuttering is also referred to as stammering, especially in England, and by a broader term, dysfluent speech.

[0006] Characteristics of stuttering are described in Section 307.0 of the DSM-IV at pp. 63-65. While all individuals are dysfluent at times, the person who stutters is differentiated from someone with normal speech disfluencies by the kind and amount of dysfluencies.

[0007] Characteristics of stuttering include: [0008] Repetition of sounds, syllables, parts of words, whole words, and phrases [0009] Prolongation, or stretching, of sounds or syllables [0010] Tense pauses, hesitations, and/or no sound between words [0011] Speech that occurs in spurts, as the client tries to initiate or maintain voice [0012] Related behaviors, for example reactions that accompany stuttering such as tense muscles in the lips, jaw, and/or neck; tremor of the lips, jaw, and/or tongue during attempts to speak; foot tapping, eye blinks, head turns, etc. (to try to escape from the stuttering); etc. There are many related behaviors that can occur and vary from person to person. [0013] Variability in stuttering behavior, depending on the speaking situation, the communication partner(s), and the speaking task. A person who stutters may experience more fluency in the speech-language pathologist's office than in a classroom or workplace. There may be no difficulty making a special dinner request at home, but extreme difficulty ordering a meal in a restaurant. Conversation with a spouse may be easier, and more fluent, than that with a boss. A person may be completely fluent when singing, but experience significant stuttering when talking on the telephone. [0014] A feeling of loss of control. The person who stutters may experience sound and word fears, situational fears, anticipation of stuttering, embarrassment, and a sense of shame. Certain sounds or words may be avoided. One word may be substituted for another that is thought to be harder to say. Or, certain speaking situations may be avoided altogether. For example, a person who stutters may always wait for someone else to answer the phone. Or, he or she may walk around a store for an hour rather than ask sales staff where an item can be found. These reactions to stuttering occur in more advanced stages.

[0015] Repetitions and prolongations are essential features of stuttering. The presence of the other listed behaviors varies from person to person.

[0016] Developmental stuttering (DS), with or without associated psychiatric illness, is the most common form, and includes all cases with gradual onset in childhood that are not the result of acquired brain damage. Persistent developmental stuttering (PDS) is DS that has not undergone spontaneous or speech therapy-induced remission. Acquired stuttering, which is much rarer than DS, may occur in previously fluent individuals. This form may be neurogenic, resulting from brain damage associated with, for example, stroke, traumatic brain injury, Alzheimer's disease, renal dialysis, Parkinson's disease, and progressive supranuclear palsy (Heuer et al. (1996) Ear Nose Throat J. 75:161-168; Brazis et al. (1996) Localization in Clinical Neurology, Third Ed., Little, Brown and Company, Boston, Mass., p.515).

[0017] Based on neuroimaging research data and the effectiveness of dopamine receptor antagonists in DS, this form of stuttering appears to have a hyperdopaminergic origin.

[0018] It is estimated that over three million Americans stutter. Stuttering affects individuals of all ages, but occurs most frequently in young children between the ages of 2 and 6 who are developing language. The prevalence of stuttering in prepubertal children is 1%, and drops to 0.8% in adolescence. The male-to-female ratio is approximately 3: 1. Most children outgrow their stuttering, and it is estimated that less than 1 percent of adults stutter.

[0019] Family and twin studies strongly suggest a genetic factor in the etiology of stuttering. The risk of stuttering among first-degree biological relatives is more than three times that in the general population. About 10% of daughters, and 20% of sons, of men who stutter will also stutter.

[0020] There is at present no cure for stuttering. However, a variety of treatments are available that may improve stuttering to some degree. These include speech therapy to improve fluency and success in communication; parent education to restructure the child's speaking environment to reduce episodes of stuttering; and the use of interventions such as electronic devices or medications. Electronic devices which help an individual control fluency may be more of a bother than a help in most speaking situations, and are often abandoned by individuals who stutter. Medications that affect brain function often have side effects that make them difficult to use for long-term treatment.

[0021] Many medications have been studied for use in treating stuttering. Evidence suggests that persons who stutter exhibit hypometabolism of the striatum and increased dopamine activity (Wu et al. (1995) Neuroreport 6:501-5; Wu et al. (1997) Neuroreport 8:767-70; Wu et al. (1997) In: Hulstijn W, Peters HRM, van Lieshout PHHM, eds. Speech production: motor control, brain research and fluency disorders. International Congress Series 1146. Amsterdam: Excerpta Medica 339-41). Drugs that boost dopamine levels exacerbate stuttering. Ritalin has a similar effect. Tricyclic antidepressants have proved ineffective, and in fact stuttering has been reported as an adverse event with the use of these compounds.

[0022] In contrast, the dopamine antagonist haloperidol has been shown in replicated, double-blind trials to reduce the symptoms of stuttering, leading to the hypothesis that D.sub.2 receptor antagonists may be important in the treatment of developmental stuttering (J. P. Brady (1991) Am. J. Psychiatry 148:1309-16). Unfortunately, as this drug is not well tolerated by this patient population and carries substantial risk of extrapyramidal symptoms and tardive dyskinesia, it is not recommended for the treatment of stuttering.

[0023] In a recent small study, Maguire et al. ((2000) J. Clin. Psychopharmacology 20:479-482) demonstrated that the serotonin-dopamine antagonist risperidone may be effective in the treatment of developmental stuttering, and recommended further investigations of risperidone for this purpose. While extrapyramidal symptoms and akathisia were not found with the use of risperidone, sedation was common, and some participants developed transient sexual and menstrual cycle side effects that resolved with discontinuance of the medication, or with a reduction in dose. These side effects are thought to be due to the elevation of the hormone prolactin by risperidone (haloperidol also raises prolactin levels in some patients).

[0024] Paroxetine and Sertraline, selective serotonin reuptake inhibitors, are also used for the treatment of stuttering, but cause a number of undesirable side effects.

[0025] Newer medications more narrowly target dopamine receptors. Olanzapine (Zyprexa), has been used successfully to treat developmental and acquired stuttering in children, adolescents, and adults (Lavid et al. (1999) Annals of Clinical Psychiatry 11(4): 233-236; Lavid et al. (2000) Presented at the annual meeting of the American Psychiatric Association, Chicago III., 2000). Side effects were mostly limited to slight weight gain and drowsiness.

[0026] The present invention addresses the need in the art for improved treatments for stuttering that are both safe and effective.

SUMMARY OF THE INVENTION

[0027] Accordingly, in a first aspect, the present invention provides a method of treating stuttering or another communication disorder, comprising administering to a patient in need of such treatment an effective amount of a selective norepinephrine reuptake inhibitor. The selective norepinephrine reuptake inhibitor can be, but is not limited to, any of the compounds disclosed herein.

[0028] In another aspect, the present invention provides the use of a selective norepinephrine reuptake inhibitor, such as any of the compounds disclosed herein, or other selective norepinephrine reuptake inhibitors, for the manufacture of a medicament for the treatment of stuttering or another communication disorder.

[0029] Further scope of the applicability of the present invention will become apparent from the detailed description provided below. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the present invention, are given by way of illustration only since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.

2 comments:

Greg said...

Patenting research methods kills innovation and is based on the greed of the individual. This is a bad thing for us, stutterers.

As one who has been on the receiving end of this relationship, I can speak from experience. That's all I have to say about that...

Now, if I have a novel idea--I actually have to consider going through the hassle of trying to patent it so I can research it w/ immunity. And if I don't go through the hassle, I have to be prepared for someone to take my idea, patent it, and then block me from researching it. This is the world in which we live...

Greg
http://stuttering.me

mbrady918 said...

A norepinephrine reuptake inhibitor. Sounds like desipramine. I wonder if I can figure a way to augment desipramine with some other meds? While I have to wait for this research?