Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1999-05-28
2001-03-06
Criares, Theodore J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S573000, C514S559000, C514S307000
Reexamination Certificate
active
06197801
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to pharmaceutical compositions for treatment of erectile dysfunction. The invention also relates to methods of administering the compositions for treatment of erectile dysfunction, including by subcutaneous (sub-q), intramuscular (IM), intracavernosal (IC), intravenous (IV), and intraarterial injection. The invention further relates to methods for reversal of erectile dysfunction by administering the compositions disclosed herein to a patient in order to improve penile circulation, which has the long-term benefit of restoring erectile function well after administration of the compositions of the invention.
BACKGROUND OF THE INVENTION
Erectile dysfunction is a serious condition which afflicts a significant percentage of the male population worldwide. This condition often has significant psychological effects which can, in severe cases, significantly reduce the quality of life for the person affected. The effects are often most severe among elderly male patients, but this condition has become increasingly prevalent within the middle-aged, and even the youthful segments of the male population.
It is believed that the parasympathetic nerve plays an important role in the regulation of erectile function. As noted above, impotence is most frequent in the elderly male population. Impotence is also a frequent affliction among male patients who have undergone prostatectomy, either for treatment of prostate cancer or an enlarged prostate condition. In fact, although numerous patients are candidates for removal of enlarged prostate, many elect not to have the surgery, and to live with the effects of an enlarged prostate, because they fear loss of normal erectile function. In addition to prostatectomy, several other causes have been linked to erectile dysfunction, including diabetes, psychological causes, surgery (including lower back which affects the parasympathetic nerve), trauma, obesity, smoking, or any other condition which constricts or restricts the arteries or reduces blood flow.
There are currently five methods available for treatment of erectile dysfunction. First, a prostaglandin-E1 product (Muse, Vivus) is available for intra urethral administration. Injectable products include products comprising prostaglandin-E1 for intramuscular/intracavernosal injection. None of these products interact with all of the important receptors or with the parasympathetic nerve. In fact, injectable products including only prostaglandin-E1 have been shown to have an efficacy of no greater than 50%. Moreover, none of these products have shown any efficacy for reversal of erectile dysfunction, and therefore injection or administration must be repeated each time an erection is desired. Further drawbacks of these injectable preparations are that they produce pain and unnatural erection, in addition to the difficulties of injection. In addition to these pharmaceutical treatments for erectile dysfunction, implants have also been used for treatment of erectile dysfunction. These include both permanently rigid implants (e.g., Erectaid), as well as implants having pumping capabilities, and which therefore can be deflated after use.
Thus, a product is needed for treatment of erectile dysfunction having an efficacy of greater than 50%. Moreover, a product is needed for reversal of erectile dysfunction, a product for which one or a few administrations will restore to the patient normal erectile function. Moreover, a pharmaceutical product is needed for treatment of impotence in male patients who have undergone prostatectomy, surgery (including lower back which affects the parasympathetic nerve), trauma, or who suffer from diabetes, psychological causes of impotence, obesity, smoking, or any other condition which constricts or restricts the arteries or reduces blood flow.
SUMMARY OF THE INVENTION
The present invention relates to injectable pharmaceutical compositions as described below for treatment of erectile dysfunction. We have discovered that prostaglandin E-1, in combination with other agents disclosed herein, can be used successfully as a vasodilator for treatment of erectile dysfunction, and even for reversal to cause recovery from erectile dysfunction. Thus, in certain embodiments, the preparation includes prostaglandin E-1 in an amount effective to cause erection in a patient experiencing erectile dysfunction. In another embodiment the preparation will include additional vasodilators, such as antimuscarinics, e.g., d,L-hyoscyamine and/or dicyclomine HCl. In other embodiments the preparation will include further vasodilators, such as calcium channel blockers, e.g., verapamil and/or diltiazem HCl. In other embodiments the preparation will also include levsin and/or additional vasodilators, such as smooth muscle relaxants, e.g., 6,7-dimethoxy-1-veratrylisoquinoline HCl. In other embodiments the preparation will also include chlorpromazine, a pharmaceutical having vasodilating action due to its effect on the autonomic nervous system and direct action on blood vessels.
The invention also relates to preparations which include one or more agents to enhance the ability of the preparation to reverse erectile dysfunction by providing long-term improvement of penile circulation. For example, the injectable pharmaceutical composition of the invention may include vitamin B-12, vitamin B-6, folic acid, and/or tissue plasminogen activator.
The methods of the invention include methods for treatment of a patient having erectile dysfunction, and determination of reversal of erectile dysfunction. The physician provides a pharmaceutical composition having an effective amount of prostaglandin E-1, and optionally further having effective amounts of one or more of levsin, verapamil and 6,7-dimethoxy-1-veratrylisoquinoline HCL. The patient is injected with the pharmaceutical composition. The injection will typically occur in the penis, but may also occur elsewhere in the body. Injection may be subcutaneous, intracavernosal or intramuscular, and may also occur systemically (i.e., intravenous or intra-arterial).
Before, during, and after injection, the patient may be diagnostically monitored to determine the increase in penile hemodynamic function (circulation), in order to quantitatively or semi-quantitatively determine the effectiveness of treatment or reversal of erectile dysfunction. Any diagnostic technique useful to monitor or detect perfusion or blood circulation may be used. Useful techniques include ultrasound, MRI, CT, and X-ray (fluoroscopy), and any of these techniques may further include the use of contrast agents which are well known and commercially available. Techniques for measuring hemodynamic parameters include those disclosed in Place, U.S. Pat. No. 5,482,039, incorporated herein by reference.
In other methods of the invention, the pharmaceutical composition will further include effective amounts of additional vasodilating agents, such as diltiazem HCl, d,L-hyoscyamine, dicyclomine HCl, chlorpromazine. In still other methods, the composition will include one or more agents which enhance the ability of the preparation to reverse erectile dysfunction by providing long-term improvement of penile circulation. These compositions thus effect treatment which restores normal erectile function to the patient. For example, the injectable pharmaceutical composition may include effective amounts of vitamin B-12, vitamin B-6, folic acid, and/or tissue plasminogen activator.
DETAILED DESCRIPTION
In a first embodiment the injectable pharmaceutical compositions for treatment of erectile dysfunction includes prostaglandin E-1 in an amount effective to cause an erection in a patient experiencing erectile dysfunction. In another embodiment the preparation will also include levsin and/or additional vasodilators, such as verapamil, and may optionally further include 6,7-dimethoxy-1-veratrylisoquinoline HCl. The effective amount of prostaglandin E-1 will typically be 0.0001-60 &mgr;g, more preferably 0.001-60 &mgr;g, more preferably 0.01-60 &mgr;g, more preferably 0.1-60 &mg
Criares Theodore J.
Kim Jennifer
USA Doctors Products, Inc.
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