Antares Pharma Reports on Their Study Using Testosterone Subcutaneous Injections

[Nelson Vergel]

EWING, N.J., Jul 22, 2014 (BUSINESS WIRE) -- Antares Pharma, Inc. today announced that the first patient has been dosed in a double-blind, multiple-dose, phase 3 study to evaluate the efficacy and safety of QuickShot® Testosterone (QS T) administered subcutaneously once each week to testosterone-deficient adult males. Patients enrolled in this study must have a documented diagnosis of hypogonadism, or testosterone deficiency defined as having testosterone levels below 300 ng/dL. The study will include a screening phase, a treatment titration and efficacy phase and an extended treatment phase.

Eamonn P. Hobbs, President and Chief Executive Officer, stated, “We are very excited to announce that the first patient has been dosed in the phase 3 QS T study of testosterone-deficient adult males. The QS T delivery system could potentially fill a patient need for a more precise and convenient dosing regimen in the growing testosterone replacement market.” Mr. Hobbs continued, “Our proprietary QuickShot system is designed for pain-free subcutaneous administration of a weekly fixed dose of testosterone through a fine gauge needle in a matter of seconds. We look forward to working closely with the U.S. Food and Drug Administration to bring this novel product to an expanding market.”

Approximately 150 patients will be enrolled in this study. Patients meeting all eligibility criteria will be assigned to receive a starting dose of QS T once weekly for six weeks. Adjustments to dose may be made at week seven based upon the week six pre-dose blood level. The efficacy of QS T and dose adjustment to regulate testosterone levels will be evaluated after 12 weeks of treatment. Upon completion of this phase, patients may remain on their optimized QS T dose and will be followed for an additional 40 weeks. Approximately 100 patients will be needed to complete collection of 26 weeks of safety data, and approximately 50 patients will be needed to complete collection of 52 weeks of safety data.

 

[Eli1947]

unfortunatly I had to stop sc injection of test. ennanate made with regular syringe due to loal unexplained issue at the injection sites.

 

[Dr. John Crisler]

unfortunatly I had to stop sc injection of test. ennanate made with regular syringe due to loal unexplained issue at the injection sites.

That does not mean you would have the same reaction under this test study protocol.

 

[Eli1947]

That does not mean you would have the same reaction under this test study protocol.

True Dr Crisler.
It is fortunate that this company is going to register this route of administration eg SC at this schedule of treatment to be authorized and not off lable! So many more can benifite from this easy rout of administratin as many MD refuse prescribing sc and split dose. Other pharma avoid investing in new clinical trial making this route and schedule of administratin autorized.
I tried to invesitigate what kind of formulation they are using it should be some where as I used the the only formulation available at my place , Bayer formulation in castor oil benzylbenzoate.

 

[Nelson Vergel]

Their product will be approved with an injector. It will be high cost. Using compounded testosterone cypionate or enanthate plus insulin syringes will still be cheaper and better.

 

[Eli1947]

Nelson, according to their publication the treatment is Testo-En. http://clinicaltrials.gov/ct2/show/study/NCT02159469
Is it going to be sold prefilled like BAYER's IM ?
It is not clear to me whether they are going to rely on known formulation of an existing NDA
and add the device or going full NDA which is much more expensive.
Of course the product will be costly as they will have exclusivity rights due to thier patented device and if the go all the way with new formulation even may have better situation.
I am curious to know this information but could not locate their clinical trial protocol.
This information should have been published somewhere. Do you have an idea about it?

 

[Nelson Vergel]

The injector will look like this:

 

[Eli1947]

Thanks. eg probably the formulation is not yet relesed .

 

[Nelson Vergel]

They are using the same testosterone enanthate that we use now.

 

[Eli1947]

They are using the same testosterone enanthate that we use now.

what do you mean? I try to understand what is the vehicle composition they are using in their final phase 3 . e.g Oil preservative etc (inactives) testosterone enanthate is the active) . AT http://clinicaltrials.gov/show/NCT01887418 phase 1 and 2 they desined the trail with two compositions of QuickShot™ which they identified as combination A and B vs the Reference listed drug Drug: Delatestryl/needle/syringe.
The present phase 3, there is one composition at 3 strengths against the RLD.
I woder what is the combination , combination of what? It may indicate that they invented some thing new in regard to composition requiered for SC injection. As such I am going to look if there is a published new patent application in regard to composition of the vehicle.

 

[HarryCat]

I woder what is the combination , combination of what?

It's the combination of the delivery mechanism and the drug, the Quickshot injector and the testosterone enanthate for the first 2 arms, and a syringe, needle and testosterone enanthate (Delatestryl) for the third arm.

 

[dunemedic]

It looks like SQ is gaining in acceptance. I am still reeling from the fact my physician discharged me for simply asking if he would consider breaking my IM into smaller SQ injections per week. I simply sent him a study and asked him to consider it. His response was completely disproportionate to my request. I am still looking for another physician that will use the regimen of Test Cyp and HCG and an AI if needed.
I find this totally absurd. Am I not a partner in my own healthcare? Don't I have a say? I did not demand a change in my treatment. I did not dictate my course of therapy. Now what? I only have enough medication for another month at best and I don't have the disposable income as yet as I am still a student.

 

[Eli1947]

dunemedic- you have the right to be involved in your treatment but it the physition right to prescribe or not. So you know that you can vote with your feet. Go find a different MD you are comfortable with and find whether you realy need the extra medications. You do not need MD who just prescribe just because you wish to. I know it is not always easy to do so.There is the problem of availabilty of MD and of that stuff that make the world go around eg money. Keep the spirt and make your best to help yourself.

 

[dunemedic]

Eli,
Thanks for the advice. I know I can vote with my feet, I have done it already with one Endocrinologist that refused to use HCG with my Tgel. I was having marked atrophy and I brought him the info on HCG and asked if he would prescribe it. He said no he did not do that and that I should find a "Hormone Clinic". So I told him I wanted another doc. My primary said the same thing.
My issue now is money is tight right now while I am in school and the extra money for the right Doc, like Dr. Crisler is out of my "reach" at the current moment.
I believe I have the right to ask questions about my treatment and have input into what is done with my body since I am the one that has to deal with the symptoms and side effects. I believe in todays world you need to be an informed patient. The days of Marcus Welby are over. Just like with anything else you have people, like Dr. Crisler, that are exceptional at what they do and understand it a level most do not. Physicians that are innovators. Then there are others who are ok at what they do, then there are people that are not good and harm others either through their lack of knowledge, or skill or some that just don't care.
The problem with this last Dr. was I only suggested he consider it and his reaction was totally disproportionate to the situation. Now, maybe there are other circumstances going on with him that I am not privy to. Irrespective of that to discharge me for asking a question and leaving me to fend for myself. I told him how hard it was to find someone. Total lack of professionalism. I am glad I did not give Nelson his name to publish on the list of TRT docs. No one should be treated this way.

 

[Eli1947]

dunemedic , sorry that I can't help, I am located at the other side of the globe. Recall that at the ******** forum Jasen Bruse was mentioned as a person that can help , look for the post of Joel Vail posted July 24 at 7:09pm · Tucson, AZ, United States

 

[dunemedic]

Eli, Thank you. I guess I am just venting at this point. I am just blown away as I work in health care and would never treat anyone like this.

 

[Eli1947]

Venting is OK. Try venting toward solving the problem. all best.

 

[dunemedic]

Thank you. I know the solution, just not sure I can afford it right now.

 

[Nelson Vergel]

Antares Pharma Announces Positive Top-Line Pharmacokinetic Results From The Quickshot® [Subcutaneous Injection] Phase 3 Study In Testosterone Deficient Men
http://www.sec.gov/Archives/edgar/data/1016169/000119312515061057/d880836dex991.htm


Antares Pharma, Inc. (NASDAQ: ATRS) today announced positive top-line pharmacokinetic results that showed that the primary endpoint was achieved in the Company’s ongoing, multi-center, phase 3 clinical study (QST-13-003) evaluating the efficacy and safety of testosterone enanthate administered once-weekly by subcutaneous injection using the QuickShot® auto injector in testosterone deficient adult males.


In the study, 150 adult males with hypogonadism (low testosterone) and testosterone blood levels less than 300 ng/dL received a starting dose of 75 mg of subcutaneously administered testosterone enanthate (QuickShot® Testosterone, or QS T) once weekly for six weeks.


Blinded adjustments to dose were made when necessary at week seven based upon the week six pre-dose blood level, and full pharmacokinetic (PK) profiles were obtained during the 12th week of treatment.


The protocol for the study required that at the week 12 endpoint:
(i) at least 75% of all patients’ Cavg are within the normal range of 300 to 1100 ng/dL, with a lower limit of a 95% 2-sided confidence interval of greater than or equal to 65%,
(ii) at least 85% of patients’ Cmax are less than1500 ng/dL and
(iii) no more than 5% of patients had a Cmax greater than 1800 ng/dL.


The primary endpoint of the population that received one or more doses of QS T was met by 139 out of 150 patients, equating to 92.7% with a 95% confidence interval of 87.3% to 96.3%. Among the 137 patients that completed all 12 weeks of dosing and PK sampling, 98.5% were within the pre-defined range.

 

[J2048b]

isnt there a website where u can elect to join certain trials? i saw it one time and there were a bunch of trials being offered so i wondered if u knew of any vergel?