Major Depressive Disorder
Generalized Anxiety Disorder
Sexual Dysfunction in Females
Major Depressive Disorder:
Since the 1970’s tremendous progress has been made in the treatment of MDD. Prozac, the first of the SSRIs, and Effexor, the first of the SNRIs, have ushered in a group of medications which have had significant impact on the treatment of MDD. Perhaps the most important element of this progress has been the training of physicians to recognize and treat MDD making treatment more available and safer. All of these drugs have made the treatment of MDD safer.
Significant work remains to be done. The SSRIs and SNRIs are not as effective as the tricyclics. Fully 40% of those with MDD do not respond to the newer drugs. The drugs are not effective in the treatment of severe depression, or atypical depression. Many of these newer drugs cause weight gain and/or have withdrawal phenomenon. And finally, these drugs cause sexual dysfunction in many patients, causing patients to be reluctant to take them or quit taking them prematurely.
At Fabre-Kramer our focus is progress in these areas. We strive to develop new medications to address these unmet needs.
Our portfolio includes:
A medication with multiple mechanisms of action to effectively treat severe depression
Medications that relieve depression without causing sexual dysfunction, and actually improve sexual function.
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Generalized Anxiety Disorder:
In the 1970s and 1980s, Valium and other benzodiazepines were used extensively to treat GAD. The drugs were terrific at reducing anxiety symptoms but caused memory loss, sedation, habituation, addiction and other serious problems. In many states, there are now severe restrictions on the prescribing of benzodiazepines and, in general, physicians have come to fear their use.
More recently, buspirone and the SSRIs and SNRIs have been approved for the treatment of GAD. Buspirone is a weak anxiolytic which does not treat somatic anxiety, a major source of discomfort for GAD sufferers. The SNRIs and SSRIs seem to have efficacy. Some, but not all, have shown efficacy in somatic as well and psychic anxiety. However, the adverse effects of sexual dysfunction, weight gain, and withdrawal phenomenon are still prevalent.
At Fabre-Kramer we have focused on new medications to solve these problems.
Our portfolio includes medications similar to, but much stronger than, buspirone to treat psychic and somatic anxiety while improving sexual function, and medications similar to benzodiazepines that work at a different part of the benzodiazepine receptor to reduce anxiety without causing addiction, sedation, or memory impairment.
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Sexual Dysfunction in Females:
The issue of sexual dysfunction in men has been well studied and the Viagra-like drugs have extended the useful sexual lives of millions of men. Unfortunately, these drugs do not work for women. Efforts to treat sexual dysfunction in women, especially lack of desire, have not been successful. In general, hormonal treatments have been proposed. The FDA has been concerned with the potential of hormonal treatments to cause or worsen cancer. Therefore, currently there are no approved treatments for sexual dysfunction in women.
At Fabre-Kramer we have focused on this problem.
Fabre-Kramer has several non-hormonal drugs that improve sexual function in women. Currently our focus is on Hypoactive Sexual Desire Disorder (HSDD), although we have evidence that our drugs increase arousal and orgasm as well.
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The phenothiazines, introduced in the 1950’s, relieved hallucinations and delusions in schizophrenics and emptied out the psychiatric hospitals. The phenothiazines decreased dopaminergic transmission in the limbic system, which was beneficial but also in the cerebral cortex which made the patients unable to think and function. The introduction of the 5-HT2-D2 antagonists such as Zyprexa represented a huge improvement. The decreased dopaminergic transmission was limited to the limbic region and the patient was able to think and function and even work. However, problems with this class of drugs have emerged. These include huge weight gains, a metabolic syndrome, and the onset of diabetes. Further, the patients will not take the medication on a regular basis and return to psychotic thinking and thus further hospitalization.
At Fabre-Kramer we have medications to address these problems.
Fabre-Kramer has an antipsychotic that, because of its specific receptor binding characteristics, does not appear to cause the weight gain and metabolic problems seen with current drugs. This compound is extremely potent and could potentially be administered as an implant. This would allow patients to function for months at a time, without the need to take daily doses.
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The advent of L-DOPA represented the first real effective treatment of Parkinson’s Disease. L-DOPA works because the affected pre-synaptic neurons are by-passed for a post-synaptic effect. The initial promise for this drug however, has faded since it was discovered that L-DOPA loses efficacy with time, causing so-called off periods. The drug also causes the adverse event of involuntary movements. Current research in Parkinson’s Disease is aimed at genetic solutions which may take decades to perfect.
Fabre-Kramer has anti-Parkinson compounds which work directly on the post-synaptic neurons more effectively than L-DOPA. These drugs would be expected to be effective during off periods. In animal models they do not cause dyskinesia and have demonstrated efficacy for extended periods of time.