Scottsdale, AZ, United States
Scottsdale, AZ, United States

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Burnett B.P.,Primus Pharmaceuticals Inc. | Levy R.M.,Primus Pharmaceuticals Inc.
Advances in Therapy | Year: 2012

Cyclooxygenase (COX)-1, COX-2, and 5-lipoxygenase (5-LOX) enzymes produce effectors of pain and inflammation in osteoarthritis (OA) and many other diseases. All three enzymes play a key role in the metabolism of arachidonic acid (AA) to inflammatory fatty acids, which contribute to the deterioration of cartilage. AA is derived from both phospholipase A 2 (PLA 2) conversion of cell membrane phospholipids and dietary consumption of omega-6 fatty acids. Nonsteroidal antiinflammatory drugs (NSAIDs) inhibit the COX enzymes, but show no anti-5-LOX activity to prevent the formation of leukotrienes (LTs). Cysteinyl LTs, such as LTC 4, LTD 4, LTE 4, and leukoattractive LTB 4 accumulate in several organs of mammals in response to NSAID consumption. Elevated 5-LOX-mediated AA metabolism may contribute to the side-effect profile observed for NSAIDs in OA. Current therapeutics under development, so-called "dual inhibitors" of COX and 5-LOX, show improved side-effect profiles and may represent a new option in the management of OA. © 2012 Springer Healthcare.


Pillai L.,Primus Pharmaceuticals Inc. | Burnett B.P.,Primus Pharmaceuticals Inc. | Levy R.M.,Primus Pharmaceuticals Inc.
Current Medical Research and Opinion | Year: 2010

Objectives: GOAL (Gauging Osteoarthritis [OA] with Limbrel *Limbrel is manufactured by Primus Pharmaceuticals, Inc., Scottsdale, AZ, USA.*), an open-label, post-marketing study was performed to determine the overall efficacy and gastrointestinal (GI) tolerability of flavocoxid, a novel, plant-based, anti-inflammatory medication, in a real world clinical practice setting. To this end, the study enrolled several unique patient types including nonsteroidal anti-inflammatory drug (NSAID) nave patients, those who had used NSAIDs in the past, regardless of outcome (positive or negative), and those who had previously taken a gastroprotective medication to improve GI tolerability or continued to take it as a precautionary measure to prevent NSAID-associated GI damage. Methods: A total of 1067 individuals at 41 rheumatology practices were enrolled and prescribed flavocoxid, 500mg b.i.d., for 60 days. The Physician Global Assessment of Disease (PGAD) visual analog scale (VAS) was used as a global measure to assess the signs and symptoms of OA, including joint discomfort, functional stiffness, functional mobility and quality of life. In addition, overall tolerability and upper GI tolerability were assessed by individual questions scored on a 5-part Likert scale. The physicians also monitored any interruption in, or cessation of use of flavocoxid due to a GI issue as well as changes in the use of gastroprotective medications. Adverse event (AE) monitoring was also conducted. Results: Of the 1005 patients who completed all follow-up visits, physicians recorded an average improvement in VAS scores from 60.118.8 at baseline to 42.521.9 at 8 weeks (p<0.001) in 65.8 of patients. The PGAD VAS noted the most significant improvement in those patients with moderate to severe OA (baseline VAS [0least severe, 100most severe]: 025mm,-3.56.9; 2650mm,-10.117.0; 5175mm,-19.319.5; 76100mm,-29.623.6; p<0.001) and in those patients who were historically non-responders to NSAIDs (40.321.1 vs. 66.317.7 at baseline; p<0.001). Patients who had previously responded well to NSAIDs had VAS scores of 42.619.8 vs. 58.018.0 (p<0.001) and NSAID nave subjects showed improvement in VAS scores from 60.518.0 at baseline to 46.323.7 (p<0.001). The study recorded a low incidence (10) of AEs reported to physicians and good overall tolerability to flavocoxid. Flavocoxid showed improved upper GI tolerability in almost 50 of previous NSAID users (p<0.001) and reduced therapy interruption in 90 of previous NSAID users with a history of GI-related therapy interruptions (p<0.0001). Finally, the use of flavocoxid resulted in a >30 reduction in or cessation of the use of gastroprotective medications such as proton pump inhibitors (PPI) or histamine-2 receptor antagonists (H2s) in subjects (p<0.001). Conclusions: Within a real world clinical rheumatology practice setting, flavocoxid demonstrated significant efficacy in the management of OA in multiple patient types and displayed significant potential for reducing the possibility of adverse GI side-effects and use of gastroprotective agents associated with more traditional OA medications. A limitation of this study was that it was open-label and not rigorously controlled. The large population may compensate for this lack of control. © 2010 Informa UK Ltd All rights reserved.


Patent
Primus Pharmaceuticals Inc. | Date: 2010-01-26

The invention relates to methods of treating Duchenne muscular dystrophy with flavonoids. The methods may include (a) providing a pharmaceutical composition comprising a therapeutically effective amount of flavonoid, and (b) administering the composition to a human patient, wherein the flavonoid comprises an isoflav-4-one with at least one of the carbons located at positions 8, 7, 6, 5, 2, 2, 3, 4, 5, or 6 modified by an alcohol group. Alternatively, the flavonoid may comprise (1) a flavan-3-ol with at least one of the carbons located at positions 8, 7, 6, 5, 4, 2, 3, 4, 5, or 6 modified by an alcohol group, or (2) a Free-B-Ring flavone with at least one of the carbons located at positions 8, 7, 6, 5 or 3 modified by an alcohol group and with at least one of the carbons located at positions 8, 7, 6, 5 or 3 modified by a glycoside group.


Patent
Primus Pharmaceuticals Inc. | Date: 2012-11-26

Combined therapies and oral dosage forms based on genistein for the support of osteoporotic health.


Patent
Primus Pharmaceuticals Inc. | Date: 2012-06-01

The invention relates to methods of treating Duchenne muscular dystrophy with flavonoids. The methods may include (a) providing a pharmaceutical composition comprising a therapeutically effective amount of flavonoid, and (b) administering the composition to a human patient, wherein the flavonoid comprises an isoflav-4-one with at least one of the carbons located at positions 8, 7, 6, 5, 2, 2, 3, 4, 5, or 6 modified by an alcohol group. Alternatively, the flavonoid may comprise (1) a flavan-3-ol with at least one of the carbons located at positions 8, 7, 6, 5, 4, 2, 3, 4, 5, or 6 modified by an alcohol group, or (2) a Free-B-Ring flavone with at least one of the carbons located at positions 8, 7, 6, 5 or 3 modified by an alcohol group and with at least one of the carbons located at positions 8, 7, 6, 5 or 3 modified by a glycoside group.


Trademark
Primus Pharmaceuticals Inc. | Date: 2014-07-07

Topical creams, gels, ointments, foams and lotions for dermatological uses.


Patent
Primus Pharmaceuticals Inc. | Date: 2015-03-18

Combined therapies and oral dosage forms based on genistein for the support of osteoporotic health.


Trademark
Primus Pharmaceuticals Inc. | Date: 2015-07-20

Topical hormone preparations.


Trademark
Primus Pharmaceuticals Inc. | Date: 2013-06-04

Medical foods for the dietary management of low bone density, osteopenia, osteoporosis; medical foods for the dietary management of the symptoms of menopause; pharmaceutical preparations for the prevention or treatment of low bone density, osteopenia, osteoporosis; pharmaceutical preparations for the treatment of the symptoms of menopause.


Trademark
Primus Pharmaceuticals Inc. | Date: 2015-07-20

Topical hormone preparations.

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