Teva Pharmaceutical Industries Ltd (TEVA) started a rolling submission of the New Drug Application (:NDA) in the U.S. for CEP-33237 (hydrocodone bitartrate extended-release tablets) which utilizes its proprietary technology providing potential abuse-deterrent properties.

Teva expects to complete the rolling submission by the end of the year. The company is seeking approval for the candidate to manage severe pain in patients who require daily, around-the-clock, long-term opioid treatment. For these patients alternative treatment options are also inadequate.

Moreover, Teva announced positive results from the nasal Human Abuse Liability (HAL) study on CEP-33237. Results from the HAL study also support the above submission. Results from the study revealed that the abuse potential for crushed intranasal CEP-33237 was significantly lower in non-dependent, recreational opioid users as compared to intranasal immediate-release hydrocodone.

We remind investors that according to the top-line results from a pivotal phase III study, announced in April this year, treatment with CEP-33237 resulted in significant improvement in chronic low back pain.

We are encouraged by Teva’s pipeline updates in the recent past. The company has several regulatory decisions pending. We expect investor focus to remain on these decisions.

We note that Teva recently announced that it will primarily focus on its core therapeutic areas — central nervous system and respiratory. The company also plans to streamline several pipeline programs. We are encouraged by the company’s strategic updates as both the central nervous system and respiratory markets are highly lucrative (read more: Teva to Concentrate on Core Specialty Therapeutics).

Teva carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharmaceutical sector are Actavis (ACT), Mylan, Inc. (MYL) and Mallinckrodt (MNK). All the stocks carry a Zacks Rank #1 (Strong Buy).

Read the Full Research Report on TEVA
Read the Full Research Report on MYL
Read the Full Research Report on MNK
Read the Full Research Report on ACT


Zacks Investment Research