Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
1999-06-04
2001-08-21
Azpuru, Carlos A. (Department: 2165)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S501000, C424S502000
Reexamination Certificate
active
06277391
ABSTRACT:
CROSS REFERENCE TO RELATED APPLICATIONS
This application claims priority under 37 C.F.R. 119 from earlier filed application No. KR98-20895, filed Jun. 5, 1998, in the Korean Patent Office.
THE FIELD OF THE INVENTION
The present invention relates generally to a method of treating diseases and disorders of the prostate such as prostatitis, benign prostatic hypertrophy, and prostate carcinoma. More particularly, it concerns making treatment by injecting a biodegradable sustained release formulation directly into the prostate.
BACKGROUND OF THE INVENTION
Prostate diseases such as prostatitis, benign prostatic hypertrophy, prostatodynia, and prostate carcinoma afflict many adult males. The largest population of men stricken with prostate problems are those over age fifty. However, inherited prostate problems can appear in much younger men.
Prostatitis is generally an inflammation of the prostate gland and the surrounding tissue. Several causes of inflammation are known and have been categorized by the National Institute of Health. Category I is recognized as acute bacterial prostatitis. Category II is chronic bacterial prostatitis. Category III includes chronic abacterial prostatitis and CPPS (Chronic Pelvic Pain Syndrome). Category IIIA is inflammatory CPPS, and Category IIIB is non-inflammatory CPPS. Finally, Category IV encompasses asymptomatic inflammatory prostatitis.
Category I, acute bacterial prostatitis, has been quite effectively managed in the past using a wide spectrum of antibiotics. Category II, chronic bacterial prostatitis, is most often treated with higher potency drugs for management such as Quinolone or Trimethoprim therapy for as long as needed. Attempts at treating Category IIIA, inflammatory CPPS, have been made using a wide variety of antibiotic and anti-inflammatory agents.
Administration of treatment substances through the bloodstream has been less than satisfactory in treating prostate diseases. Large doses of treatment substance have been required for effective treatment. Therefore, it is now believed that a filtering barrier exists between the prostate and the body's blood supply which prevents treatment substances from entering the prostate. The problematic effect of this barrier is two fold. First, the barrier prevents most of the treatment substance dosage from entering the prostate and having a therapeutic effect. Second, the barrier mandates extremely high doses of the treatment substance in order to have a therapeutic effect. Since most of the drug is not allowed into the prostate it remains in the body's general circulation. This results in many undesirable side effects.
In an attempt to reduce the need of high doses of strong antibiotics and other treatment substances, many urologists have turned to injecting treatment substances directly into the prostate. Although this procedure has yielded greater therapeutic results at much lower doses, frequent repetition of injections is generally required to obtain adequate treatment results. This frequent injection repetition causes much pain, discomfort, and inconvenience to the patient.
Benign prostatic hypertrophy is a condition where the prostate over-grows or becomes enlarged. Prostate growth is controlled by androgen receptors found in the prostate gland. When the androgen receptors are stimulated by 5 &agr;-dihydrotesterone (DHT), they cause the prostate to grow. DHT is produced by an enzymatic conversion of testosterone in the prostate.
The main treatments for benign prostatic hypertrophy have been drug therapy and surgery. Transurethral resection of the prostate (TURP) is the most widely used surgical treatment procedure. The most widely used drug therapy has been the bloodstream administration of an &agr;-blocker such as terazosin or doxazosin. Additionally, bloodstream administration of a 5 &agr;-reductase inhibitor such as finasteride has been used. These drugs, however, often have the undesirable side effects of postural hypotension or impotence, and decreased libido. Additionally, these drugs must be continually administered for the duration of the patient's life in order to prevent a return of the problem.
One new method of treating benign prostatic hypertrophy is the intraprostatic injection of a collagenase, hyaluronidase mixture. This mixture effectively dissolves prostatic tissue which has the ultimate effect of shrinking the prostate. However, since this treatment does nothing to prevent further prostate growth, the treatment must reapplied as frequently as new prostate growth demands.
Prostate carcinoma is a neoplasm which most frequently affects men over 50 years old and is a leading cause of cancer deaths in men. Radical prostatectomy or surgical removal of the prostate, and radiation therapy are the most common treatment methods for prostate carcinoma. However, radical prostatectomy often results in impotence and urinary incontinence. Radiation therapy, while having a somewhat lower cure rate than surgery, is generally well tolerated. However, radiation therapy has also been known to produce impotence, incontinence, cystitis, and proctitis.
In addition to surgery and radiation therapy, other methods for treating prostate carcinoma have been employed. One such method is the intramuscular or subcutaneous injection of a sustained release depot formulation which contains LHRH agonists. This method is not without adverse side effects, such as prolonged systemic exposure to high doses of the formulation. Another, more recent treatment method is the intraprostatic or intralesional injection of alpha interferon. This method too has the unfortunate requirement of frequent repetitive injections over a substantial period of time.
In view of the foregoing, a method of treating prostate diseases and disorders which minimizes adverse side effects as well as a patient's pain and discomfort is highly desirable. Further, a method of treatment which allows effective therapeutic results with lower doses of the treatment substance is desirable. Additionally, a method of treatment which produces a sustained delivery of the treatment substance over long periods of time is desirable.
OBJECTS AND SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide an injectable pharmaceutically acceptable composition for the treatment of prostatic diseases and disorders, including but not limited to, prostatitis, benign prostatic hypertrophy, and prostate carcinoma.
It is an additional object of the present invention to provide a method for treating diseases of the prostate which requires a significantly smaller dose than the presently known treatments, but which yields similar or better treatment results.
It is yet another object of the present invention to provide a method for treating prostate diseases and disorders with an intraprostatic injection which does not need to be frequently re-administered or repeated.
The above objects and others not specifically recited are realized in a few specific illustrative embodiments of an injectable treatment composition. The treatment composition generally includes at least one therapeutically effective substance for treatment of prostatic diseases and disorders. It may however contain a combination of these substances.
When the specific disease or disorder is prostatitis, this therapeutically effective substance is selected from the group consisting of antibiotics, anti-inflammatory drugs, and mixtures thereof. Additionally, when the specific disease or disorder is benign prostatic hypertrophy, the therapeutically effective substance is selected from the group consisting of &agr;-blockers, 5 &agr;-reductse, cytotoxic drugs, anti-angiogenetic drugs, and mixtures thereof. Finally, when the specific disease or disorder is prostate carcinoma, the therapeutically effective substance is an anticancer agent. This anticancer agent is often a member selected from the group consisting of alkylating agents, cytotoxic antibiotics, steroid hormones, vinca alkaloids, anti-angiogenetic agents, and mixtures thereof.
Whatever the specific t
Choi In Ja
Kim Jee Hyang
Lee Jae Yong
Seo Min Hyo
Azpuru Carlos A.
Samyang Corporation
Thorpe North & Western, llp
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